Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

NCT01517932 | Completed Phase 4 DMC

• 1 other identifier: TJMU-A-201106
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Restlessness; Pain

Outcome Measures

Primary Outcomes (1)

• Emergence agitation

  Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours

  during 0-3 postoperative hours

Secondary Outcomes (6)

• Postoperative pain at rest

  At 1,3 postoperative hours

• dosage Dosage of analgesics

  during 3 postoperative hours

• Recovery time

  At the moment of the eyes opend when calling the names

• Postoperative sedation

  at 0,1,3 postoperative hours

• Extubation time

  at the moment of extubation

Study Arms (2)

Group-DEX

EXPERIMENTAL

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

Drug: dexmedetomidine

Group-PLB

PLACEBO COMPARATOR

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

Drug: saline placebo

Interventions

dexmedetomidine 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-DEX

saline placebo 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

Group-PLB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fang Luo: lead

MeSH Terms

Conditions

Psychomotor Agitation; Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fang Luo, MD.PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology

Study Record Dates

• First Submitted: January 22, 2012
• First Posted: January 25, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 20, 2013

Record last verified: 2013-03