Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA

NCT05344911 | Completed Phase 4 DMC

• 1 other identifier: xijing2022-0410
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

functional endoscopic sinus surgery; postoperative pain; afentanil or remifentanil

Outcome Measures

Primary Outcomes (1)

• 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

  Postoperative 30minutes

Study Arms (2)

remifentanil

ACTIVE COMPARATOR

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

Drug: Propofol combined with remifentanil

alfentanil

EXPERIMENTAL

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

Drug: Propofol combined with alfentanil

Interventions

Propofol combined with alfentanil DRUG

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)

alfentanil

Propofol combined with remifentanil DRUG

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)

remifentanil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

YANLI

XIan, Shanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 28928100 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Alfentanil; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Yan Jia

  The First Affiliated Hospital of the Air Force Medical Universtiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: April 29, 2022
• Primary Completion: July 20, 2022
• Study Completion: August 30, 2022
• Last Updated: January 19, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)