Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
Information source: Nanjing Medical University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Fentanyl citrate (Drug); Sufentanil citrate (Drug); Butorphanol tartrate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nanjing Medical University Official(s) and/or principal investigator(s):
XiaoFeng Shen, MD, Study Chair, Affiliation: Nanjing Medical University
Overall contact:
FuZhou Wang, MD, Phone: 86-25-84460777, Ext: 3301, Email: zfwang50@gmail.com
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.
Clinical Details
Official title: Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: VAS ratings of pain
Secondary outcome: Hemodynamics of patientsSedative ratings with VAS system Overall VAS satisfaction ratings Blood cortisol and β-endorphin levels Side effects
Eligibility
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
FuZhou Wang, MD, Phone: 86-25-84460777, Ext: 3301, Email: zfwang50@gmail.com
Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu 210004, China; Recruiting
YuZhu Peng, MD, Phone: 86-25-84460777, Ext: 1508, Email: pyz1131@hotmail.com
XiRong Guo, MD, Phone: 86-25-84460777, Ext: 1508, Email: xrguonjmueducn@yahoo.com.cn
YuSheng Liu, MD, Sub-Investigator
Additional Information
Starting date: July 2008
Ending date: March 2009
Last updated: February 11, 2009
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