Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

Postoperative Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141412
• Other study ID #: ANES.MA.10
• Status: Completed
• Phase: Phase 4
• Start date: September 2009
• Est. completion date: September 2015

Study information

• Verified date: June 2018
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Emergence
• Anesthesia Recovery
• Postoperative Recovery
• Shivering

Intervention

Drug:
• dexmedetomidine 0.25 µg/kg IV

• dexmedetomidine 0.5 µg/kg IV

• dexmedetomidine 1 µg/kg IV

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

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postanaesthetic shivering incidence and score		change from baseline every 10 minutes up to 1 hour post-operatively
Primary	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	Patient's Temperature		every 10 minutes up to 1 hour post-operatively
Secondary	Time to extubation, awakening and orientation		1 hour post-operatively
Secondary	Sedation scores		every 10 minutes up to 1 hour post-operatively
Secondary	Pain scores		every 10 minutes up to 1 hour post-operatively
Secondary	Nausea and vomiting		every 10 minutes up to 1 hour post-operatively