Dexmedetomidine in Post Spinal Anesthesia Shivering

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02382432

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.

Condition or Disease	Intervention/Treatment	Phase
Shivering Caused by Spinal Anesthesia	Drug: Pethidine 0.4mg/kg Drug: Dexmedetomidine	Phase 2

Detailed Description

Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.

Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pethidine 0.4mg/kg iv interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.	Drug: Pethidine 0.4mg/kg 2ml intravenous bolus slowly injected in 2minutes. Other Names: Meperidine
Active Comparator: DEX. I Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.	Drug: Dexmedetomidine 2ml intravenous bolus slowly injected in 2minutes Other Names: Precedex
Active Comparator: DEX. II Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.	Drug: Dexmedetomidine 2ml intravenous bolus slowly injected in 2minutes Other Names: Precedex
Active Comparator: DEX III Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.	Drug: Dexmedetomidine 2ml intravenous bolus slowly injected in 2minutes Other Names: Precedex

Outcome Measures

Primary Outcome Measures

Shivering response rate (%) [10 minutes]
complete cessation of shivering activity within 10 minutes after study drug injection

Secondary Outcome Measures

Systolic blood pressure [6 hours after study drug injection]
find for systolic hypotension, hypertension
sedation [6 hours after study drug injection]
using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking).
peripheral arterial saturation [6 hours after study drug injection]
find for hypoxia
diastolic blood pressure [6 hours after study drug injection]
find for diastolic hypertension or hypotension
Postoperative adverse events [24 hours postoperative]
postoperative nausea and vomiting, urine retention, post dural puncture headache ect.

Other Outcome Measures

heart rate [6 hours after study drug injection]
find for bradycardia or tachycardia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period