Anesthesia Emergence, Anesthesia Recovery, Postoperative Recovery, Shivering
Conditions
Keywords
optimal dose of dexmedetomidine, prevent shivering, improve quality of emergence, anesthesia, without delay, recovery
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.
Interventions
DRUGdexmedetomidine 0.25 µg/kg IV
DRUGdexmedetomidine 1 µg/kg IV
DRUGPlacebo Comparator
Patients in Group IV will receive same volume of normal saline at closure of sevoflurane
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postanaesthetic shivering incidence and score | change from baseline every 10 minutes up to 1 hour post-operatively | — |
| Quality of emergence from anesthesia | 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
| Measure | Time frame |
|---|---|
| Sedation scores | every 10 minutes up to 1 hour post-operatively |
| Patient's Temperature | every 10 minutes up to 1 hour post-operatively |
| Nausea and vomiting | every 10 minutes up to 1 hour post-operatively |
| Pain scores | every 10 minutes up to 1 hour post-operatively |
| Time to extubation, awakening and orientation | 1 hour post-operatively |
Countries
Lebanon
Outcome results
None listed