Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.

NCT03356899 | Completed

• 1 other identifier: MenoufiaU2015/2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.

Conditions

Cesarean Section; Shivering

Outcome Measures

Primary Outcomes (1)

• Shivering score

  Shivering score is a graded score using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalised movement; and 4, shivering involving the movement of the whole body.

  Peri-operatively

Secondary Outcomes (2)

• Mean arterial blood pressure (mmHg)

  Peri-operatively

• Heart rate (beat/minute)

  Peri-operatively

Study Arms (2)

Low dose bupivacaine 0.5% (8mg)

ACTIVE COMPARATOR

Bupivacaine 0.5% for spinal anesthesia

Drug: Low dose bupivacaine 0.5% (8mg)

High dose bupivacaine 0.5% (10mg)

ACTIVE COMPARATOR

Bupivacaine 0.5% for spinal anesthesia

Drug: High dose bupivacaine 0.5% (10mg)

Interventions

Low dose bupivacaine 0.5% (8mg) DRUG

8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml

Also known as: Bupivacaine for spinal anaesthesia.

Low dose bupivacaine 0.5% (8mg)

High dose bupivacaine 0.5% (10mg) DRUG

10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5

Also known as: Bupivacaine for spinal anaesthesia

High dose bupivacaine 0.5% (10mg)

Eligibility Criteria

• Age: 22 Years - 35 Years
• Gender Eligibility Details: All patients were females scheduled for elective caesarian section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section.

You may not qualify if:

• Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine, Menoufia Univeristy

Shibīn al Kawm, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ezzeldin Ibrahim, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: November 29, 2017
• Study Start: December 30, 2017
• Primary Completion: August 29, 2018
• Study Completion: September 29, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)