Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

Minia University99 enrolled

Overview

The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.

Study groups: Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Postspinal Shivering

Interventions

DexmedetomidineDRUG

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GranisetronDRUG

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PlaceboOTHER

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Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patients scheduled for cesarean section under spinal anesthesia. * age : (20-45) years old. * American Society of Anesthesia (ASA) physical status I, II. Exclusion Criteria: * Patient refusal. * Contraindication to spinal anesthesia. * BMI \> 35 kg/m². * Impaired renal, hepatic and cardiac function. * Thyroid disease. * Body temperature \>38 °C or \< 36.5 °C.

Locations (1)

Minya University Faculty of Medicine

Minya, Egypt

Outcomes

Primary Outcomes

The incidence and severity of post spinal shivering.

-The Shivering will be graded on a scale Tsai and Chu \[Tsai et al .,2001\] : Grade 0= No shivering. Grade 1=Piloerection or peripheral vasoconstriction but no visible shivering. Grade 2=Muscular activity in only one muscle group. Grade 3=Muscular activity in more than one muscle group but not generalized. Grade 4=Shivering involving the whole body.

Time frame: every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours

Secondary Outcomes

change in the basal axillary temperature.

Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs.

Time frame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively

change in the basal mean arterial blood pressure

Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs.

Time frame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.

Change in the basal heart rate

Change in the heart rate of the patient after administration of tested drugs (beat per minute)

Time frame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.

Data from ClinicalTrials.gov

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