An interventional study of Low dose bupivacaine 0.5% (8mg) and High dose bupivacaine 0.5% (10mg) in Cesarean Section; Shivering, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Menoufia University · Not applicable, Interventional, and Other
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.
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.
Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.
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Bupivacaine 0.5% for spinal anesthesia
Drug: Low dose bupivacaine 0.5% (8mg)
Bupivacaine 0.5% for spinal anesthesia
Drug: High dose bupivacaine 0.5% (10mg)
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.
10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5
Also known as: Bupivacaine for spinal anaesthesia
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.
Time frame: Peri-operatively
Mean arterial blood pressure (mmHg)
Mean arterial blood pressure reading
Time frame: Peri-operatively
Heart rate (beat/minute)
The number of hear beats per minute
Time frame: Peri-operatively
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine