Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fang Luo, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01517932
First received: January 22, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Restlessness
Pain
Drug: dexmedetomidine
Drug: saline placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Emergence agitation [ Time Frame: during 0-3 postoperative hours ] [ Designated as safety issue: Yes ]
    Emergence agitation was assessed by the highest restlessness score(RS)during 0-3 postoperative hours


Secondary Outcome Measures:
  • Postoperative pain at rest [ Time Frame: At 1,3 postoperative hours ] [ Designated as safety issue: Yes ]
    The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale(VAS)and prince-henry score

  • dosage Dosage of analgesics [ Time Frame: during 3 postoperative hours ] [ Designated as safety issue: Yes ]
  • Recovery time [ Time Frame: At the moment of the eyes opend when calling the names ] [ Designated as safety issue: Yes ]
  • Postoperative sedation [ Time Frame: at 0,1,3 postoperative hours ] [ Designated as safety issue: Yes ]
    It was assessed by Ramsay Sedation Score(RSS)

  • Extubation time [ Time Frame: at the moment of extubation ] [ Designated as safety issue: Yes ]
  • Breathing recovery time [ Time Frame: when autonomous respiration recovered ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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

Other Name: dexmedetomidine
Placebo Comparator: 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
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

Other Name: saline placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01517932

Sponsors and Collaborators
Fang Luo
Investigators
Study Director: Fang Luo, MD.PhD Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
  More Information

No publications provided

Responsible Party: Fang Luo, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01517932     History of Changes
Other Study ID Numbers: TJMU-A-201106
Study First Received: January 22, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Psychomotor Disorders
Signs and Symptoms
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014