Comparing Prophylactic Intravenous Pethidine and Intrathecal Pethidine in Preventing Post Spinal Shivering in Caesarean Section

NCT06775431 | Recruiting Phase 3

• 1 other identifier: 0306931
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering in females undergoing caesarean section. The main question it aims to answer is: which route is more efficacious in preventing shivering. Researchers will compare IV pethidine and intrathecal pethidine to see their effects on post spinal shivering, their effects on hemodynamic stability, nausea, vomiting, and sedation.

Conditions

Pregnant Women

Keywords

post spinal shivering; IV pethidine; intrathecal pethidine; caesarean section

Outcome Measures

Primary Outcomes (4)

• Shivering incidence

  The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence of shivering

  every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively

• Onset of shivering

  The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the onset of shivering

  every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively

• Duration of shivering

  The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the duration of shivering

  every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively

• Shivering intensity

  The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the intensity of shivering, using the Tsai and Chu Scale The intensity of shivering using Tsai and Chu scale is measured as follows: 0: no shivering 1. piloerection or peripheral vasoconstriction, but no visible shivering 2. muscular activity in only one muscle group 3. muscular activity in more than one muscle group, but not generalized 4. shivering involving the whole body

  every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively

Secondary Outcomes (3)

• Hemodynamic stability

  at baseline and every 5 minutes after administration of the drug for 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes in the first 2 hours postoperatively

• Incidence of vomiting

  from administration of spinal till 2 hours postoperatively

• Incidence of sedation

  from administration of spinal till 2 hours postoperatively

Other Outcomes (1)

• Body Temperature

  before administration of the drug, then every 15 minutes till the end of surgery and every 30 minutes for 2 hours postoperatively

Study Arms (2)

IVGroup

ACTIVE COMPARATOR

This group will receive IV 0.5mg/kg Pethidine as premedication mixed into 10 ml normal saline slowly IV

Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Intrathecal Group

ACTIVE COMPARATOR

This group will receive intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5%

Drug: Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally

Interventions

Pethidine Hydrochloride 50 Mg/mL Solution for Injection DRUG

Pethidine will be administered intravenously in group A 0.5 mg/kg as premedication

IVGroup

Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally DRUG

0.2 mg/kg pethidine in trathecally will be administered with bupivacaine 0.5% in group B

Intrathecal Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant females undergoing caesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• contraindications to spinal
• uncontrolled hypertension, diabetes mellitus, hepatic, pulmonary diseases, and thyroid disease
• obesity (BMI \>35)
• drug allergy
• temperature below 36 degrees celcius or above 37.5 degrees celcius

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

El-Shatby University Hospital

Alexandria, Alexandria Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Meperidine; Solutions; Injections

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Mai A El-Sayed, Lecturer of Anesthesia

CONTACT

00201287459922; m_mohamed165@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 15, 2025
• Study Start: December 10, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-10

Locations

EG (1)