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NCT Number: NCT02141412

Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.

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Key information

Conditions

Anesthesia Recovery Anesthesia Emergence Postoperative Recovery Shivering

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 year-old
  • ASA class I, II, and III
  • patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h

Exclusion criteria

  • duration of surgery less than 1h or more than 3 h
  • allergy to dexmedetomidine
  • vasoactive antidepressant or analgesics
  • obesity (BMI>30)
  • fever
  • pregnancy

Treatment and study plan

dexmedetomidine 0.25 µg/kg IV

Drug

dexmedetomidine 0.5 µg/kg IV

Drug

dexmedetomidine 1 µg/kg IV

Drug

placebo comparator

Drug

Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Primary outcomes

  1. Postanaesthetic shivering incidence and score

    Time frame: change from baseline every 10 minutes up to 1 hour post-operatively

  2. Quality of emergence from anesthesia

    Time frame: Change from baseline every 5 minutes till extubation

    The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation

Secondary outcomes

  1. Patient's Temperature

    Time frame: every 10 minutes up to 1 hour post-operatively

  2. Time to extubation, awakening and orientation

    Time frame: 1 hour post-operatively

  3. Sedation scores

    Time frame: every 10 minutes up to 1 hour post-operatively

  4. Pain scores

    Time frame: every 10 minutes up to 1 hour post-operatively

  5. Nausea and vomiting

    Time frame: every 10 minutes up to 1 hour post-operatively

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
Jun 27, 2018

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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