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Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA (TIVA)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Propofol combined with alfentanil
Propofol combined with remifentanil
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring functional endoscopic sinus surgery, postoperative pain, afentanil or remifentanil

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-65 years old
  • ASA Ⅰ-Ⅲ
  • patients undergoing functional endoscopic sinus surgery under general anesthesia.

Exclusion Criteria:

  • Significant hypertension (diastolic blood pressure > 100mmHg) or hypotension (systolic . blood pressure < 100mmHg).
  • severe mental, cardiovascular, kidney or liver disease.
  • previous history of alcohol or drug abuse.
  • long-term use of painkillers before operation.
  • contraindications for any drugs used in the study.

Sites / Locations

  • YANLI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

remifentanil

alfentanil

Arm Description

Anesthesia maintenance:target-controlled infusion of propofol combined with remifentanil)

Anesthesia maintenance:target-controlled infusion of propofol combined with afentanil

Outcomes

Primary Outcome Measures

VAS score
the digital rating scale (VAS) uses a number between 0 and 10 to indicate that there is no pain; a score of 1-3 means that a slight pain can be tolerated; a score of 4-6 indicates that it is bearable if it does not affect sleep; a score of 7-10 indicates that it is becoming more and more painful and unbearable, affecting appetite and sleep

Secondary Outcome Measures

Full Information

First Posted
April 18, 2022
Last Updated
January 16, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05344911
Brief Title
Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA
Acronym
TIVA
Official Title
Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA Undergoing Functional Endoscopic Sinus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. It has a slight effect on respiration and circulation, strong controllability, short anesthetic recovery time, reduced postoperative nausea and vomiting (PONV) and quick discharge time, so it has been widely used in clinic. Functional endoscopic sinus surgery is a common method for the treatment of sinusitis and other diseases. The trauma of this operation is less. The use of TIVA during the operation can reduce the bleeding in the surgical field and is beneficial to the recovery of patients. The combination of propofol and remifentanil is the most common in TIVA because of its fast pharmacokinetics and short half-life. However, the disadvantage of remifentanil is the lack of residual analgesic effect after termination of continuous infusion. As postoperative nasal packing can still bring postoperative pain, patients with severe discomfort caused by pain will have unexpected conditions such as surgical incision cracking and bleeding, which will affect the effect of operation and rehabilitation. Afentanil is another opioid drug with short effect and strong analgesic effect. Previous studies have shown that remifentanil-based TIVA has slightly higher postoperative pain and early use of analgesics than TIVA in discectomy. Because the effect of TIVA using Afentanil or remifentanil on postoperative pain in functional nasal endoscopic surgery is not clear, this study intends to observe the effect of TIVA on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia, so as to optimize the clinical anesthetic scheme of this kind of minimally invasive surgery and provide clinical reference.
Detailed Description
This study intends to observe the effect of TIVA using afentanil or remifentanil on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia. Main indicators: VAS score at 30 min after operation. Secondary indicators: VAS score of 60 min after operation. VAS score of 24h after operation. Number of cases of postoperative use of analgesics . Number of cases of postoperative adverse reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
functional endoscopic sinus surgery, postoperative pain, afentanil or remifentanil

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
remifentanil
Arm Type
Active Comparator
Arm Description
Anesthesia maintenance:target-controlled infusion of propofol combined with remifentanil)
Arm Title
alfentanil
Arm Type
Experimental
Arm Description
Anesthesia maintenance:target-controlled infusion of propofol combined with afentanil
Intervention Type
Drug
Intervention Name(s)
Propofol combined with alfentanil
Intervention Description
Anesthesia induction: midazolam 0.02 mg/kg, propofol(TCI) 3 μ g/mL, alfentanil 20 μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with alfentanil(0.5-2ug/kg/min)
Intervention Type
Drug
Intervention Name(s)
Propofol combined with remifentanil
Intervention Description
Anesthesia induction: midazolam 0.02 mg/kg, propofol(TCI) 3 μ g/mL, remifentanil 1μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with remifentanil(0.1-0.3ug/kg/min)
Primary Outcome Measure Information:
Title
VAS score
Description
the digital rating scale (VAS) uses a number between 0 and 10 to indicate that there is no pain; a score of 1-3 means that a slight pain can be tolerated; a score of 4-6 indicates that it is bearable if it does not affect sleep; a score of 7-10 indicates that it is becoming more and more painful and unbearable, affecting appetite and sleep
Time Frame
Postoperative 30minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-65 years old ASA Ⅰ-Ⅲ patients undergoing functional endoscopic sinus surgery under general anesthesia. Exclusion Criteria: Significant hypertension (diastolic blood pressure > 100mmHg) or hypotension (systolic . blood pressure < 100mmHg). severe mental, cardiovascular, kidney or liver disease. previous history of alcohol or drug abuse. long-term use of painkillers before operation. contraindications for any drugs used in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Jia
Organizational Affiliation
The First Affiliated Hospital of the Air Force Medical Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
YANLI
City
XIan
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28928100
Citation
Doganay G, Ekmekci P, Kazbek BK, Yilmaz H, Erkan G, Tuzuner F. Effects of alfentanil or fentanyl added to propofol for sedation in colonoscopy on cognitive functions: Randomized controlled trial. Turk J Gastroenterol. 2017 Nov;28(6):453-459. doi: 10.5152/tjg.2017.16489. Epub 2017 Sep 19.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28928100/
Description
Doğanay G, Ekmekçi P, Kazbek BK, et al. Effects of alfentanil or fentanyl added to propofol for sedation in colonoscopy on cognitive functions: Randomized controlled trial. Turk J Gastroenterol. 2017 ,28(6):453-459.

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Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA

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