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Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function

Primary Purpose

Cervix Neoplasms, Endometrial Cancer, Adenomyosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the drug of intravenous patient-controlled analgesia
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervix Neoplasms

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. patients who were scheduled for laparoscopic hysterectomy from W&C BRANCH HOSPITAL OF JIANGSU PROVINCE HOSPITAL
  2. American Society of Anesthesiologists (ASA) physical status classification 1 to 2,
  3. Women aged 40-65
  4. Weight 50-80 kg

Exclusion Criteria:

  1. History of opioids abuse and allergy and contraindication to opioid drugs
  2. bronchial asthma; coronary heart disease; severe hypertension; diabetes mellitus;
  3. hepatic, and renal dysfunction (glutamyl aminotransferase> 40U or aspartate aminotransferase> 35U; urea nitrogen> 8.2 μmol / L, creatinine> 133 μmol / L),
  4. History of brain damage or psychiatric disease
  5. Patients with coagulopathy (PT> 17 seconds or activated partial thromboplastin time (APTT)> 47 seconds);
  6. pregnant or lactating women;
  7. Those with long-term constipation;
  8. History of digestive diseases;
  9. history of gastrointestinal disease (peptic ulcer disease, Crohn's disease, or ulcerative colitis)
  10. Participants in other drug trials in the past three months. (11)After randomization and allocation, patients were withdrawn if laparoscopy was converted to open surgery or if they required reinvestigation for postoperative bleeding.

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Fentanyl group(group F)

Oxycodone group(group O)

Butorphanol group(group B)

Arm Description

Fentanyl citrate injection, specification: 10mL: 0.5mg / piece (production unit: niching chang rendu Pharmaceutical Co., Ltd., valid period: 48 months) For group F patients,0.5mg fentanyl was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes

Oxycodone hydrochloride injection, specification: 1mL: 10mg / branch (production unit: HAMOL LIMITED, valid period: 60 months) For group O patients,30mg oxycodone was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes

Butorphanol tartrate injection, specification: 1 mL: 1 mg / branch (production unit: Jiangsu henryi Pharmaceutical Co., Ltd., valid period: 24 months); For group B patients,10mg butorphanol was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes

Outcomes

Primary Outcome Measures

postoperative time to first anal exhaust
Timing from the end of the operation
the cumulative dose administered in the patient-controlled mode
The cumulative dose administered in the patient-controlled mode during the initial 48 hours after the operation was measured
effective bolus times
The effective bolus times in the patient-controlled mode during the initial 48 hours after the operation was measured

Secondary Outcome Measures

pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Sedation score
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Sedation score
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Sedation score
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Sedation score
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
adverse effects
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa) and pruritus
adverse effects
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial carbon dioxide (CO2)tension >6.66 kPa) and pruritus
adverse effects
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus
adverse effects
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus
patients' degree of overall satisfaction with the postoperative analgesia
Patients were asked to evaluate their degree of overall satisfaction with the postoperative analgesia on a 11-point scale (0= very unsatisfied, 1-3= unsatisfied, 4-6 = neutral, 7-9= satisfied, or 10 = very satisfied).
postoperative hospitalization days
All patients were cured in accordance with clinical cure standard

Full Information

First Posted
January 5, 2020
Last Updated
April 21, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04295109
Brief Title
Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function
Official Title
Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function in Patients Undergoing Laparoscopic Hysterectomy: a Double-blind, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Postoperative ileus (POI) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication.So,how to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function?This was a prospective randomized controlled study. A total of 105 patients who were scheduled for laparoscopic hysterectomy were randomly selected from The First Affiliated Hospital with Nanjing Medical University by random number table. These patients were randomly divided into three groups: fentanyl(F) group, oxycodone(O) group and butorphanol(B) group.
Detailed Description
Background: Patients often experience pain after gynecological laparoscopy. However, the use of opioid analgesia after surgery may increase the incidence of postoperative ileus (POI). Postoperative ileus (POI) is a common surgical emergency after a surgical procedure, leading to infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. How to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function? There is no guideline which has been troubling clinical anesthesiologists. Aims: To observe the effects of fentanyl, oxycodone, Butorphanol on the recovery of gastrointestinal function after laparoscopic hysterectomy. Methods: A total of 105 patients undergoing laparoscopic hysterectomy were randomly divided to three groups: fentanyl group(group F), butorphanol group(group B), or oxycodone group(group O). The primary outcome measures were postoperative time to first anal exhaust the total analgesic doses in PCIA,effective bolus times. Patients were also assessed for pain with a visual analogue scale (VAS), the cumulative PCIA dose, adverse effects (Nausea,vomiting, bradycardia, respiratory depression and pruritus), sedation level at 4, 12, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours and postoperative hospitalization days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Neoplasms, Endometrial Cancer, Adenomyosis, Fibroid Uterus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl group(group F)
Arm Type
Active Comparator
Arm Description
Fentanyl citrate injection, specification: 10mL: 0.5mg / piece (production unit: niching chang rendu Pharmaceutical Co., Ltd., valid period: 48 months) For group F patients,0.5mg fentanyl was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
Arm Title
Oxycodone group(group O)
Arm Type
Experimental
Arm Description
Oxycodone hydrochloride injection, specification: 1mL: 10mg / branch (production unit: HAMOL LIMITED, valid period: 60 months) For group O patients,30mg oxycodone was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
Arm Title
Butorphanol group(group B)
Arm Type
Experimental
Arm Description
Butorphanol tartrate injection, specification: 1 mL: 1 mg / branch (production unit: Jiangsu henryi Pharmaceutical Co., Ltd., valid period: 24 months); For group B patients,10mg butorphanol was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
Intervention Type
Drug
Intervention Name(s)
the drug of intravenous patient-controlled analgesia
Other Intervention Name(s)
intravenous patient-controlled analgesia (IV-PCA)
Intervention Description
At present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.
Primary Outcome Measure Information:
Title
postoperative time to first anal exhaust
Description
Timing from the end of the operation
Time Frame
From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days
Title
the cumulative dose administered in the patient-controlled mode
Description
The cumulative dose administered in the patient-controlled mode during the initial 48 hours after the operation was measured
Time Frame
From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
Title
effective bolus times
Description
The effective bolus times in the patient-controlled mode during the initial 48 hours after the operation was measured
Time Frame
From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
Secondary Outcome Measure Information:
Title
pain score
Description
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time Frame
at 4 hours postoperatively
Title
pain score
Description
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time Frame
at 12 hours postoperatively
Title
pain score
Description
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time Frame
at 24 hours postoperatively
Title
pain score
Description
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time Frame
at 48 hours postoperatively
Title
Sedation score
Description
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Time Frame
at 4 hours postoperatively
Title
Sedation score
Description
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Time Frame
at 12 hours postoperatively
Title
Sedation score
Description
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Time Frame
at 24 hours postoperatively
Title
Sedation score
Description
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
Time Frame
at 48 hours postoperatively
Title
adverse effects
Description
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa) and pruritus
Time Frame
at 4 hours postoperatively
Title
adverse effects
Description
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial carbon dioxide (CO2)tension >6.66 kPa) and pruritus
Time Frame
at 12 hours postoperatively
Title
adverse effects
Description
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus
Time Frame
at 24 hours postoperatively
Title
adverse effects
Description
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus
Time Frame
at 48 hours postoperatively
Title
patients' degree of overall satisfaction with the postoperative analgesia
Description
Patients were asked to evaluate their degree of overall satisfaction with the postoperative analgesia on a 11-point scale (0= very unsatisfied, 1-3= unsatisfied, 4-6 = neutral, 7-9= satisfied, or 10 = very satisfied).
Time Frame
at 48 hours postoperatively
Title
postoperative hospitalization days
Description
All patients were cured in accordance with clinical cure standard
Time Frame
From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients who were scheduled for laparoscopic hysterectomy from W&C BRANCH HOSPITAL OF JIANGSU PROVINCE HOSPITAL American Society of Anesthesiologists (ASA) physical status classification 1 to 2, Women aged 40-65 Weight 50-80 kg Exclusion Criteria: History of opioids abuse and allergy and contraindication to opioid drugs bronchial asthma; coronary heart disease; severe hypertension; diabetes mellitus; hepatic, and renal dysfunction (glutamyl aminotransferase> 40U or aspartate aminotransferase> 35U; urea nitrogen> 8.2 μmol / L, creatinine> 133 μmol / L), History of brain damage or psychiatric disease Patients with coagulopathy (PT> 17 seconds or activated partial thromboplastin time (APTT)> 47 seconds); pregnant or lactating women; Those with long-term constipation; History of digestive diseases; history of gastrointestinal disease (peptic ulcer disease, Crohn's disease, or ulcerative colitis) Participants in other drug trials in the past three months. (11)After randomization and allocation, patients were withdrawn if laparoscopy was converted to open surgery or if they required reinvestigation for postoperative bleeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cunming Liu, doctorate
Phone
13951890866
Email
1335587409@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Minna Guo, Master
Phone
18835162576
Email
1653474602@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cunming Liu, doctorate
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shijiang Liu, Master
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chuanbao Han
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Minna Guo
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cunming Liu
Phone
13951890866
Email
1335587409@qq.com
First Name & Middle Initial & Last Name & Degree
Minna Guo
Phone
18835162576
Email
1653474602@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35209847
Citation
Guo M, Liu S, Gao J, Han C, Yang C, Liu C. The effects of fentanyl, oxycodone, and butorphanol on gastrointestinal function in patients undergoing laparoscopic hysterectomy: a prospective, double-blind, randomized controlled trial. BMC Anesthesiol. 2022 Feb 24;22(1):53. doi: 10.1186/s12871-022-01594-9.
Results Reference
derived

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Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function

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