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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Butorphanol tartrate; Drug: Fentanyl citrate; Drug: Sufentanil citrate

• Registration Number: NCT00738192
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-20
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-10
• Last Update Posted: 2009-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Butorphanol tartrate	Butorphanol delivered for controlling awaking pain
1	Fentanyl citrate	Fentanyl delivered for controlling awaking pain
2	Sufentanil citrate	Sufentanil delivered for controlling awaking pain

Primary Outcome Measures

Name	Time	Method
VAS ratings of pain	0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia

Secondary Outcome Measures

Name	Time	Method
Hemodynamics of patients	30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation
Sedative ratings with VAS system	0,5,10,15,25,45 and 60min after awake from anesthesia
Overall VAS satisfaction ratings	1 h after operation
Blood cortisol and β-endorphin levels	0, 10min before the end of surgeries, 10min, 1h and 6h after operation
Side effects	1 h after operation

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China