Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

NCT ID: NCT01517932

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-12-31

Brief Summary

Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.

In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.

Detailed Description

Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery

Conditions

Restlessness; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group-DEX

Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery

Group Type: EXPERIMENTAL

dexmedetomidine

Intervention Type: DRUG

In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.

Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.

Patients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery

Group-PLB

Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery

Group Type: PLACEBO_COMPARATOR

saline placebo

Intervention Type: DRUG

In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.

Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.

Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery

Interventions

dexmedetomidine

In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.

Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.

Patients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery

Intervention Type: DRUG

saline placebo

In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.

Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.

Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
• undergoing selective thoracotomy
• weight between 45 and 75kg
• operation time 2-4 hours

Exclusion Criteria

• history of neurologic disease
• history of chronic analgesics intake
• history of allergic reactions to the experimental durgs
• history of renal insufficiency
• history of hepatic dysfunction
• history of coagulation disorders
• women in lactation
• participating in other studies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fang Luo

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fang Luo, MD.PhD

Role: STUDY_DIRECTOR

Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China

Other Identifiers

TJMU-A-201106

Identifier Type: -

Identifier Source: org_study_id