Dexmedetomidine in Post Spinal Anesthesia Shivering

Assiut University120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Shivering Caused by Spinal Anesthesia

Interventions

Pethidine 0.4mg/kgDRUG

2ml intravenous bolus slowly injected in 2minutes.

DexmedetomidineDRUG

2ml intravenous bolus slowly injected in 2minutes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Assiut university hospital, Assiut, Egypt

Asyut, Assiut Governorate, Egypt

Outcomes

Primary Outcomes

Shivering response rate (%)

complete cessation of shivering activity within 10 minutes after study drug injection

Time frame: 10 minutes

Secondary Outcomes

Systolic blood pressure

find for systolic hypotension, hypertension

Time frame: 6 hours after study drug injection

sedation

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).

Time frame: 6 hours after study drug injection

peripheral arterial saturation

find for hypoxia

Time frame: 6 hours after study drug injection

diastolic blood pressure

find for diastolic hypertension or hypotension

Time frame: 6 hours after study drug injection

Postoperative adverse events

postoperative nausea and vomiting, urine retention, post dural puncture headache ect.

Time frame: 24 hours postoperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.