An interventional study of fentanyl and fentanyl in Cesarean Section, sponsored by Dr. Soliman Fakeeh Hospital. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2015-10-20.
Sponsored by Dr. Soliman Fakeeh Hospital · Not applicable, Interventional, and Prevention
Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.
Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.
Design: A randomized, controlled clinical trial.
Setting: Single medical center from 5/2013 to 10/2014.
Patients \& Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.
Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Dr. Soliman Fakeeh Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
fentanyl and hyperbaric bupivacaine (sequentially)
Drug: fentanyl · Drug: Hyperbaric bupivacaine
fentanyl and hyperbaric bupivacaine.(mixed)
Drug: fentanyl · Drug: hyperbaric bupivacaine
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
Time frame: intraoperative
incidence of hypotension
Time frame: intraoperative
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Dr. Soliman Fakeeh Hospital