Post Spinal Anesthesia Shivering
Conditions
Keywords
Cesarean Section, Dexmedetomidine, Intrathecal Anesthesia, Shivering
Brief summary
This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia
Detailed description
The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure. Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut). Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence
Interventions
DRUGpreservative-free 0.9% saline.
(0.5 ml) preservative-free 0.9% saline
DRUGdexmedetomidine 3mcg group
3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
DRUGdexmedetomidine 5mcg
5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double (Participant, Care Provider)
Intervention model description
parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. * singleton pregnancy * Age: 20 \ 40 years; * ASA physical status II \ III;
Exclusion criteria
* parturient less than 20 years and more than 40 years. * History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease. * parturients who had allergy to any medication in the study. * parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity) * parturient who has history of alcohol intake. * parturient received any medication likely to affect thermoregulation or Veno dilation. * Refusing to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy on the incidence and severity of shivering associated with spinal anesthesia. | Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later | evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse effects | Immediately after spinal anesthesia, and within 90 minutes later | the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation. |
Countries
Egypt
Contacts
Primary ContactMohamed A. Mahmoud, MD
Outcome results
None listed