Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia - Full Text View

Sponsor:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00738192

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Butorphanol Sufentanil Butorphanol tartrate Sufentanil citrate Citric acid Remifentanil hydrochloride Remifentanil Fentanyl Fentanyl Citrate Sodium Citrate

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hemodynamics of patients [ Time Frame: 30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation ] [ Designated as safety issue: Yes ]
Sedative ratings with VAS system [ Time Frame: 0,5,10,15,25,45 and 60min after awake from anesthesia ] [ Designated as safety issue: Yes ]
Overall VAS satisfaction ratings [ Time Frame: 1 h after operation ] [ Designated as safety issue: Yes ]
Blood cortisol and β-endorphin levels [ Time Frame: 0, 10min before the end of surgeries, 10min, 1h and 6h after operation ] [ Designated as safety issue: No ]
Side effects [ Time Frame: 1 h after operation ] [ Designated as safety issue: Yes ]

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
1: Active Comparator Fentanyl delivered for controlling awaking pain	Drug: Fentanyl citrate Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
2: Active Comparator Sufentanil delivered for controlling awaking pain	Drug: Sufentanil citrate Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
3: Active Comparator Butorphanol delivered for controlling awaking pain	Drug: Butorphanol tartrate Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMU-FY2008-311, NJFY0807311M
Study First Received:	August 18, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00738192 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Postoperative analgesia
Opioids
Laparoscopic surgery

Additional relevant MeSH terms:

Respiratory System Agents
Fentanyl
Physiological Effects of Drugs
Narcotic Antagonists
Anesthetics
Butorphanol
Pain
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Pain, Postoperative

Analgesics, Opioid
Anesthetics, Intravenous
Remifentanil
Central Nervous System Depressants
Narcotics
Sufentanil
Pharmacologic Actions
Adjuvants, Anesthesia
Postoperative Complications
Anesthetics, General
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010