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

NCT00738192 | Completed Phase 4 DMC

• 2 other identifiers: NMU-FY2008-311NJFY0807311M
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Postoperative analgesia; Opioids; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• VAS ratings of pain

  0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia

Secondary Outcomes (5)

• Hemodynamics of patients

  30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation

• Sedative ratings with VAS system

  0,5,10,15,25,45 and 60min after awake from anesthesia

• Overall VAS satisfaction ratings

  1 h after operation

• Blood cortisol and β-endorphin levels

  0, 10min before the end of surgeries, 10min, 1h and 6h after operation

• Side effects

  1 h after operation

Study Arms (3)

1

ACTIVE COMPARATOR

Fentanyl delivered for controlling awaking pain

Drug: Fentanyl citrate

2

ACTIVE COMPARATOR

Sufentanil delivered for controlling awaking pain

Drug: Sufentanil citrate

3

ACTIVE COMPARATOR

Butorphanol delivered for controlling awaking pain

Drug: Butorphanol tartrate

Interventions

Fentanyl citrate DRUG

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

Also known as: Fentanil

1

Sufentanil citrate DRUG

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

Also known as: Sufenil

2

Butorphanol tartrate DRUG

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

Also known as: Nuoyung

3

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II
• Chinese
• Selective laparoscopic surgeries

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Sufentanil; Butorphanol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 11, 2009

Record last verified: 2009-03

Locations

CN (1)