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

Cesarean Section; Shivering Clinical Trial

Official title:

Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356899
• Other study ID #: MenoufiaU2015/2
• Status: Completed
• Phase: N/A
• Start date: December 30, 2017
• Est. completion date: September 29, 2018

Study information

• Verified date: April 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study.

The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine).

Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery.

The severity of shivering was the primary endpoint. Shivering was graded 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 generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cesarean Section; Shivering

Intervention

Drug:
• Low dose bupivacaine 0.5% (8mg)
8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml
• High dose bupivacaine 0.5% (10mg)
10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Menoufia Univeristy	Shibin Al Kawm

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean arterial blood pressure (mmHg)	Mean arterial blood pressure reading	Peri-operatively
Secondary	Heart rate (beat/minute)	The number of hear beats per minute	Peri-operatively