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

M

Menoufia University

Status

Completed

Conditions

Cesarean Section; Shivering

Treatments

Drug: High dose bupivacaine 0.5% (10mg)
Drug: Low dose bupivacaine 0.5% (8mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT03356899
MenoufiaU2015/2

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

22 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Low dose bupivacaine 0.5% (8mg)
Active Comparator group
Description:
Bupivacaine 0.5% for spinal anesthesia
Treatment:
Drug: Low dose bupivacaine 0.5% (8mg)
High dose bupivacaine 0.5% (10mg)
Active Comparator group
Description:
Bupivacaine 0.5% for spinal anesthesia
Treatment:
Drug: High dose bupivacaine 0.5% (10mg)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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