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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane |
|
| Group II | Active Comparator | Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane |
|
| Group III | Active Comparator | Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane |
|
| Group IV | Placebo Comparator | Patients in Group IV will receive same volume of normal saline at closure of sevoflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine 0.25 µg/kg IV | Drug |
| ||
| dexmedetomidine 0.5 µg/kg IV |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Temperature | every 10 minutes up to 1 hour post-operatively | |
| Time to extubation, awakening and orientation | 1 hour post-operatively | |
| Sedation scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Aouad, MD | American Univesity of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Beirut | Lebanon |
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|
| dexmedetomidine 1 µg/kg IV | Drug |
|
| Placebo Comparator | Drug | Patients in Group IV will receive same volume of normal saline at closure of sevoflurane |
|
| 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 |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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