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Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia (CARAN)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fentanyl citrate
Sufentanil citrate
Butorphanol tartrate
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative analgesia, Opioids, Laparoscopic surgery

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA physical status I-II
  2. Chinese
  3. 19-45yr
  4. Selective laparoscopic surgeries

Exclusion Criteria:

  1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  2. Participants younger than 18 years, older than 45 years or pregnancy was eliminated
  3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
  4. Those who were not willing to or could not finish the whole study at any time

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Fentanyl delivered for controlling awaking pain

Sufentanil delivered for controlling awaking pain

Butorphanol delivered for controlling awaking pain

Outcomes

Primary Outcome Measures

VAS ratings of pain

Secondary Outcome Measures

Hemodynamics of patients
Sedative ratings with VAS system
Overall VAS satisfaction ratings
Blood cortisol and β-endorphin levels
Side effects

Full Information

First Posted
August 18, 2008
Last Updated
March 10, 2009
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00738192
Brief Title
Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
Acronym
CARAN
Official Title
Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative analgesia, Opioids, Laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Fentanyl delivered for controlling awaking pain
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sufentanil delivered for controlling awaking pain
Arm Title
3
Arm Type
Active Comparator
Arm Description
Butorphanol delivered for controlling awaking pain
Intervention Type
Drug
Intervention Name(s)
Fentanyl citrate
Other Intervention Name(s)
Fentanil
Intervention Description
Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
Intervention Type
Drug
Intervention Name(s)
Sufentanil citrate
Other Intervention Name(s)
Sufenil
Intervention Description
Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
Intervention Type
Drug
Intervention Name(s)
Butorphanol tartrate
Other Intervention Name(s)
Nuoyung
Intervention Description
Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished
Primary Outcome Measure Information:
Title
VAS ratings of pain
Time Frame
0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia
Secondary Outcome Measure Information:
Title
Hemodynamics of patients
Time Frame
30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation
Title
Sedative ratings with VAS system
Time Frame
0,5,10,15,25,45 and 60min after awake from anesthesia
Title
Overall VAS satisfaction ratings
Time Frame
1 h after operation
Title
Blood cortisol and β-endorphin levels
Time Frame
0, 10min before the end of surgeries, 10min, 1h and 6h after operation
Title
Side effects
Time Frame
1 h after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I-II Chinese 19-45yr Selective laparoscopic surgeries Exclusion Criteria: Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records Participants younger than 18 years, older than 45 years or pregnancy was eliminated Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study Those who were not willing to or could not finish the whole study at any time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia

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