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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Fentanyl citrate
* Drug: Sufentanil citrate
* Drug: Butorphanol tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fentanyl delivered for controlling awaking pain | Drug: Fentanyl citrate<br>* Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished<br>* Other names: Fentanil;|
| Active Comparator: 2<br>Sufentanil delivered for controlling awaking pain | Drug: Sufentanil citrate<br>* Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished<br>* Other names: Sufenil;|
| Active Comparator: 3<br>Butorphanol delivered for controlling awaking pain | Drug: Butorphanol tartrate<br>* Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished<br>* Other names: Nuoyung;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS ratings of pain |  | 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, Postoperative analgesia, Laparoscopic surgery