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

March 10, 2009 updated by: Nanjing Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Fentanyl delivered for controlling awaking pain
Drug: Fentanyl citrate
Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
Other Names:
  • Fentanil
ACTIVE_COMPARATOR: 2
Sufentanil delivered for controlling awaking pain
Drug: Sufentanil citrate
Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
Other Names:
  • Sufenil
ACTIVE_COMPARATOR: 3
Butorphanol delivered for controlling awaking pain
Drug: Butorphanol tartrate
Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished
Other Names:
  • Nuoyung

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (ESTIMATE)

August 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-FY2008-311
  • NJFY0807311M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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