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Completed

NCT Number: NCT01517932

Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Emergence agitation

    Time frame: during 0-3 postoperative hours

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

Secondary outcomes

  1. Postoperative pain at rest

    Time frame: At 1,3 postoperative hours

    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

  2. dosage Dosage of analgesics

    Time frame: during 3 postoperative hours

  3. Recovery time

    Time frame: At the moment of the eyes opend when calling the names

  4. Postoperative sedation

    Time frame: at 0,1,3 postoperative hours

    It was assessed by Ramsay Sedation Score(RSS)

  5. Extubation time

    Time frame: at the moment of extubation

  6. Breathing recovery time

    Time frame: when autonomous respiration recovered

Sponsors and collaborators

Lead sponsor

Fang Luo

Other

Registry information

Official study title

Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 25, 2012
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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