Cesarean Section; Shivering
Conditions
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.
Detailed 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.
Interventions
DRUGLow dose bupivacaine 0.5% (8mg)
8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml
DRUGHigh dose bupivacaine 0.5% (10mg)
10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shivering score | Peri-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure (mmHg) | Peri-operatively | Mean arterial blood pressure reading |
| Heart rate (beat/minute) | Peri-operatively | The number of hear beats per minute |
Countries
Egypt
Outcome results
None listed