Clinical trial NCT02141412: Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia
Official title: Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia Recovery
Anesthesia Emergence
Shivering
Postoperative Recovery
Keywords: optimal dose of dexmedetomidine
prevent shivering
improve quality of emergence
anesthesia
without delay
recovery
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postanaesthetic shivering incidence and score
timeFrame: change from baseline every 10 minutes up to 1 hour post-operatively
measure: Quality of emergence from anesthesia
timeFrame: Change from baseline every 5 minutes till extubation
Secondary outcomes:
measure: Patient's Temperature
timeFrame: every 10 minutes up to 1 hour post-operatively
measure: Time to extubation, awakening and orientation
timeFrame: 1 hour post-operatively
measure: Sedation scores
timeFrame: every 10 minutes up to 1 hour post-operatively
measure: Pain scores
timeFrame: every 10 minutes up to 1 hour post-operatively
measure: Nausea and vomiting
timeFrame: every 10 minutes up to 1 hour post-operatively
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American Univesity of Beirut Medical Center
name: Marie Aouad, MD
role: PRINCIPAL_INVESTIGATOR
References: