None listed
Conditions
Brief summary
Aim: To compare the effects of different doses of fentanyl added to intrathecal levobupivacaine on ephedrine requirement and to evaluate its impact on the fetus in subjects undergoing elective cesarean section. Methods: A total of 800 parturients scheduled for elective cesarean section were enrolled in the study. Those fulfilling the enrollment criteria were randomly assigned to three groups as Group I (n=266), Group II (n=274) and Group III (n=260). All patients were administered with an infusion of Ringer’s lactate solution at 10-12 mL kg-1 in the preoperative period before spinal anesthesia and at 8-10 mL kg h-1 intraoperatively. The dose of levobupivacaine 0.5% was adjusted in reference to patient heights for spinal anesthesia. While Group I was administered with levobupivacaine 0.5%, Group II was administered with levobupivacaine 0.5% + 10 microgram fentanyl and Group III was administered with levobupivacaine 0.5% + 25 microgram fentanyl. In Group II and Group III, levobupivacaine volume was decreased to compensate for the fentanyl volume. Ephedrine infusion was initiated with 5 mg bolus following the puncture for spinal anesthesia. It was then administered at 10 microgram kg-1 min-1. Ephedrine infusion was maintained with respect to baseline systolic blood pressure throughout the operation; and systolic blood pressure, heart rate, nausea-vomiting score as well as the ephedrine doses administered were recorded. Results: Total preoperative ephedrine requirement of the groups were established to be 26.07 +/- 16.39 mg in Group I, 20.72 +/- 12.95 mg in Group II and 16.80 +/- 9.40 mg in Group III. Total ephedrine used was observed to be significantly lower in Group III than in it was in Group I (p<0.05). Group I was also established with a lower mean fetal umbilical venous pH value than that observed in Group III (p<0.05). Conclusion: We conclude that the addition of 25 microgram fentanyl to levobupivacaine, when compared with the administration of levobupivacaine alone, decreases the ephedrine requirement and produces better maternal and newborn hemodynamic stability in elective cesarean section cases administered with spinal anesthesia.
Interventions
10 minute before cesarean section intrathecal levobupivacaine 0.5 % (Group I), levobupivacaine 0.5 % + 10 microgram fentanyl (Group II) and levobupivacaine 0.5 % + 25 microgram fentanyl (Group III). Following the induction of spinal anesthesia, the subjects were promptly placed in the supine position and were injected with 5 mg bolus ephedrine, followed by 10 microgram kg-1 min-1 ephedrine infusion.
Infusion was discontinued if Systolic blood pressure value reached >100% of the baseline value,
10 minute before cesarean section intrathecal levobupivacaine 0.5 % (Group I), levobupivacaine 0.5 % + 10 microgram fentanyl (Group II) and levobupivacaine 0.5 % + 25 microgram fentanyl (Group III). Following the induction of spinal anesthesia, the subjects were promptly placed in the supine position and were injected with 5 mg bolus ephedrine, followed by 10 microgram kg-1 min-1 ephedrine infusion. Infusion was discontinued if Systolic blood pressure value reached >100% of the baseline value, - Infusion was maintained at 10 microgram kg-1 min-1 if SBP value was between 80% and 100% of the baseline value, - Infusion was maintained at 20 microgram kg-1 min-1 if SBP value was <80% of the baseline value, - In addition to 5 mg bonus administration, infusion was maintained at 20 microgram kg-1 min-1 if Systolic blood pressure value was < 90 mmHg.
Sponsors
ATATURK TRAINING AND RESEARCH HOSPITAL
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
elective cesarean section
Exclusion criteria
Patients with pre-eclampsia, eclampsia, gestational hypertension, diabetes mellitus, cardiac problems or bleeding diathesis were excluded.
Outcome results
None listed