Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

NCT02141412 | Completed Phase 4

• 1 other identifier: ANES.MA.10
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Recovery; Anesthesia Emergence; Shivering; Postoperative Recovery

Keywords

optimal dose of dexmedetomidine; prevent shivering; improve quality of emergence; anesthesia; without delay; recovery

Outcome Measures

Primary Outcomes (2)

• Postanaesthetic shivering incidence and score

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

• Quality of emergence from anesthesia

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

  Change from baseline every 5 minutes till extubation

Secondary Outcomes (5)

• Patient's Temperature

  every 10 minutes up to 1 hour post-operatively

• Time to extubation, awakening and orientation

  1 hour post-operatively

• Sedation scores

  every 10 minutes up to 1 hour post-operatively

• Pain scores

  every 10 minutes up to 1 hour post-operatively

• Nausea and vomiting

  every 10 minutes up to 1 hour post-operatively

Study Arms (4)

Group I

ACTIVE COMPARATOR

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

Drug: dexmedetomidine 0.25 µg/kg IV

Group II

ACTIVE COMPARATOR

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

Drug: dexmedetomidine 0.5 µg/kg IV

Group III

ACTIVE COMPARATOR

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

Drug: dexmedetomidine 1 µg/kg IV

Group IV

PLACEBO COMPARATOR

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

Drug: Placebo Comparator

Interventions

dexmedetomidine 0.25 µg/kg IV DRUG

Group I

dexmedetomidine 0.5 µg/kg IV DRUG

Group II

dexmedetomidine 1 µg/kg IV DRUG

Group III

Placebo Comparator DRUG

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

Group IV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marie Aouad, MD

  American Univesity of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Specialty

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: September 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

LE (1)