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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738192
First Posted: August 20, 2008
Last Update Posted: March 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing Medical University
  Purpose
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.

Condition Intervention Phase
Postoperative Pain Drug: Fentanyl citrate Drug: Sufentanil citrate Drug: Butorphanol tartrate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • VAS ratings of pain [ Time Frame: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia ]

Secondary Outcome Measures:
  • Hemodynamics of patients [ Time Frame: 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 ]
  • Overall VAS satisfaction ratings [ Time Frame: 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 ]
  • Side effects [ Time Frame: 1 h after operation ]

Enrollment: 150
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Nuoyung

  Eligibility

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738192


Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00738192     History of Changes
Other Study ID Numbers: NMU-FY2008-311
NJFY0807311M
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: March 11, 2009
Last Verified: March 2009

Keywords provided by Nanjing Medical University:
Postoperative analgesia
Opioids
Laparoscopic surgery

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Fentanyl
Remifentanil
Sufentanil
Butorphanol
Analgesics
Citric Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Antitussive Agents