Dexmedetomidine in Post Spinal Anesthesia Shivering

Assiut University

Status and phase: Completed; Phase 2

Conditions: Shivering Caused by Spinal Anesthesia

Treatments: Drug: Pethidine 0.4mg/kg; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02382432

IRB00008718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups

Pethidine 0.4mg/kg iv

Active Comparator group

Description:

interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished.

Treatment:

Drug: Pethidine 0.4mg/kg

DEX. I

Active Comparator group

Description:

Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished.

Treatment:

Drug: Dexmedetomidine

DEX. II

Active Comparator group

Description:

Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.

Treatment:

Drug: Dexmedetomidine

DEX III

Active Comparator group

Description:

Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished.

Treatment:

Drug: Dexmedetomidine