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

Postoperative Pain Clinical Trial

— CARAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738192
• Other study ID #: NMU-FY2008-311
• Secondary ID: NJFY0807311M
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2008
• Last updated: March 10, 2009
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Fentanyl citrate
Fentanyl 0.5 µg/kg delivered intravenously immediate at the end of remifentanil pump finished
• Sufentanil citrate
Sufentanil 0.05 µg/kg delivered intravenously immediate at the end of remifentanil pump finished
• Butorphanol tartrate
Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS ratings of pain		0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia	Yes
Secondary	Hemodynamics of patients		30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation	Yes
Secondary	Sedative ratings with VAS system		0,5,10,15,25,45 and 60min after awake from anesthesia	Yes
Secondary	Overall VAS satisfaction ratings		1 h after operation	Yes
Secondary	Blood cortisol and ß-endorphin levels		0, 10min before the end of surgeries, 10min, 1h and 6h after operation	No
Secondary	Side effects		1 h after operation	Yes