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

NCT ID: NCT06775431

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2025-03-31

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.

Detailed Description

This study will be a single blinded, randomized, prospective controlled study. After obtaining written informed consents, 86 patients of American Society of Anesthesiologists physical status II, aged 20-40 years old, undergoing spinal anesthesia for elective cesarean section will be investigated at El-Shatby University Hospital.

The patients will be randomized into two groups of n=43 each using a computer-generated sequence. Allocation concealment will be done using sealed envelope technique. Depending on the group allocation either to receive IV Pethidine 0.5mg/kg (Group A n=43 patients) as premedication mixed into 10 ml isotonic saline slowly IV or intrathecal Pethidine 0.2 mg/kg and 2.5 ml Bupivacaine 0.5% (Group B n=43 patients). SA will be given at either L3-L4 or L4-L5 in the sitting position by the anesthetist using 22-25-gauge Quincke spinal needles. Patients will be covered with drapes but not actively warmed. 10mg ephedrine will be given if the patient becomes hypotensive (hypotension is defined as a decrease in MAP of >20% from the baseline). 0.5 mg atropine IV will be given if HR less than 50 beats/min. Rescue 4 mg ondansetron IV will be given for vomiting episodes. Room temperature will be maintained about 21 - 24ºC during the perioperative period in the OR and in the PACU, using temperature control system. The presence of shivering will be observed and graded after spinal injection by using Tsai and Chu Scale.

The following parameters will be measured:

1. Vital signs (heart rate, and blood pressure) will be measured 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 two hours postoperatively

2. Body temperature (in degrees Celsius), will be measured, using axillary thermometer before drug administration then every 15 minutes till the end of surgery. After surgery, axillary temperature will be measured every 30 minutes for 2 hours.

3. Using Tsai and Chu Scale for shivering assessment, the incidence, duration, time interval from onset of spinal block to shivering occurrence, and intensity of shivering will be recorded every 15 minutes during the surgery and every 30 minutes for 2 hours postoperatively in the recovery room.

4. Complications of the drugs, such as nausea, vomiting and sedation will be recorded.

The primary aim of this study will be to assess the effect of IV pethidine and intrathecal pethidine on the incidence, onset, duration, and intensity of shivering. The secondary aims will be to assess the effect of different routes of administration of the drug on hemodynamic stability, nausea, vomiting, and sedation.

Conditions

Pregnant Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

IVGroup

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

Group Type: ACTIVE_COMPARATOR

Pethidine Hydrochloride 50 Mg/mL Solution for Injection

Intervention Type: DRUG

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

Intrathecal Group

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

Group Type: ACTIVE_COMPARATOR

Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally

Intervention Type: DRUG

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

Interventions

Pethidine Hydrochloride 50 Mg/mL Solution for Injection

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

Intervention Type: DRUG

Pethidine Hydrochloride 50 Mg/mL Solution for Injection administered intrathecally

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

1. contraindications to spinal

2. uncontrolled hypertension, diabetes mellitus, hepatic, pulmonary diseases, and thyroid disease

3. obesity (BMI >35)

4. drug allergy

5. temperature below 36 degrees celcius or above 37.5 degrees celcius

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

El-Shatby University Hospital

Alexandria, Alexandria Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mai A El-Sayed, Lecturer of Anesthesia

Role: CONTACT

m_mohamed165@alexmed.edu.eg

00201287459922

Facility Contacts

Shahira El Metainy, Professor of Anesthesia

Role: primary

shahira.almteni@alexmed.edu.eg

00201227498438

Moutaz A Ghandour, Lecturer of Anesthesia

Role: backup

Shahira El Metainy, Professor of Anesthesia

Role: backup

Mai A El-Sayed, Lecturer of Anesthesia

Role: backup

Other Identifiers

0306931

Identifier Type: -

Identifier Source: org_study_id