Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

NCT06762860 | Unknown DMC

• 1 other identifier: postspinal shivering
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postspinal Shivering

Keywords

shivering after spinal anesthesia in cesarean section

Outcome Measures

Primary Outcomes (1)

• 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.

  every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours

Secondary Outcomes (3)

• change in the basal axillary temperature.

  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

  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

  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.

Study Arms (3)

Dexmedetomidine Group

ACTIVE COMPARATOR

Patients in this group will receive (0.3 ug/kg) intravenous dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord.

Drug: Dexmedetomidine

Granisetron Group

ACTIVE COMPARATOR

Patients in this group will receive 3mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.

Drug: Granisetron

Control Group

PLACEBO COMPARATOR

Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group).

Other: Placebo

Interventions

Dexmedetomidine DRUG

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Dexmedetomidine Group

Granisetron DRUG

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Granisetron Group

Placebo OTHER

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Control Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients scheduled for cesarean section under spinal anesthesia.
• age : (20-45) years old.
• American Society of Anesthesia (ASA) physical status I, II.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minya University Faculty of Medicine

Minya, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Granisetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of medicine -Minia University , Menna.Mamdouh@mu.edu.eg

Model Details: Group C: Patients in this group will receive 10 ml normal saline (0.9%) over 10minutes immediately after clamping of the cord (control group). Group D: Patients in this group will receive (0.3 ug/kg) intravenous Dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord. Group G: Patients in this group will receive 3 mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 28, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)