Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

American University of Beirut Medical Center

Status and phase: Completed; Phase 4

Conditions: Anesthesia Emergence; Postoperative Recovery; Anesthesia Recovery; Shivering

Treatments: Drug: dexmedetomidine 1 µg/kg IV; Drug: Placebo Comparator; Drug: dexmedetomidine 0.25 µg/kg IV; Drug: dexmedetomidine 0.5 µg/kg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT02141412

ANES.MA.10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 4 patient groups, including a placebo group

Group I

Active Comparator group

Description:

Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane

Treatment:

Drug: dexmedetomidine 0.25 µg/kg IV

Group II

Active Comparator group

Description:

Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane

Treatment:

Drug: dexmedetomidine 0.5 µg/kg IV

Group III

Active Comparator group

Description:

Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane

Treatment:

Drug: dexmedetomidine 1 µg/kg IV

Group IV

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Comparator