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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Fentanyl delivered for controlling awaking pain

Group Type ACTIVE_COMPARATOR

Fentanyl citrate

Intervention Type DRUG

Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished

2

Sufentanil delivered for controlling awaking pain

Group Type ACTIVE_COMPARATOR

Sufentanil citrate

Intervention Type DRUG

Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished

3

Butorphanol delivered for controlling awaking pain

Group Type ACTIVE_COMPARATOR

Butorphanol tartrate

Intervention Type DRUG

Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished

Interventions

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Fentanyl citrate

Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished

Intervention Type DRUG

Sufentanil citrate

Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished

Intervention Type DRUG

Butorphanol tartrate

Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished

Intervention Type DRUG

Other Intervention Names

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Fentanil Sufenil Nuoyung

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No