Clinical trial NCT02382432: Dexmedetomidine in Post Spinal Anesthesia Shivering
Official title: Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shivering Caused by Spinal Anesthesia
Keywords: Anesthesia
dexmedetomidine
pethidine
shivering
spinal
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Exclusion Criteria:

* Patients with BMI\>30 kg /m2
* Initial body temperature \>38 C or \<36 C and those with a history of convulsions
* Multiple allergies
* Thyroid disease
* Parkinson's disease
* Dysautonomia
* Raynaud's syndrome
* Hypertension
* Coronary artery disease or other cardio-respiratory or neuromuscular pathology
* Middle ear pathology
* A known history of alcohol use
* Treatment with sedative hypnotic agents or vasodilators
* Having contraindications to spinal anesthesia

Primary outcomes:
measure: Shivering response rate (%)
timeFrame: 10 minutes
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 6 hours after study drug injection
measure: sedation
timeFrame: 6 hours after study drug injection
measure: peripheral arterial saturation
timeFrame: 6 hours after study drug injection
measure: diastolic blood pressure
timeFrame: 6 hours after study drug injection
measure: Postoperative adverse events
timeFrame: 24 hours postoperative
Other outcomes:
measure: heart rate
timeFrame: 6 hours after study drug injection
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital, Assiut, Egypt
state: Assiut governorate
Study officials:
affiliation: assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.