Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04518618 |
Other study ID # |
33954/7/20 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 11, 2020 |
Est. completion date |
March 7, 2021 |
Study information
Verified date |
March 2021 |
Source |
Tanta University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant
females aged 21- 30 years presented for elective cesarean section under spinal anesthesia
where they will be randomly allocated into two equal groups:-
- Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg
hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
- Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg
hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone.
The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to
hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S.
Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the
site, and the severity of pruritis.
Description:
This prospective randomized double-blind study will be carried out on 80 female patients who
will be presented for elective C.S in the Obstetric department in Tanta university hospitals.
Full-term pregnant female aged 21- 30 years presented for elective cesarean section under
spinal anesthesia will be included in the study.
The patients will be randomly allocated into two groups by the aid of computer-generated
software of randomization. All the local anesthetic mixtures will be prepared under complete
aseptic precautions by an anesthesia resident who will not participate in the study and will
be blinded to its groups in to: - Group F (40 Patients): Patients in this group will receive
spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg
hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ugs naloxone.
Once the patient will be admitted to the operating theatre, all monitors will be applied with
introduction of 18-gauge peripheral venous cannula and starting fluid preload in the form of
lactated ringer solution 7 ml/kg over 30 minutes. While the patient in a sitting position and
under complete aseptic precautions, patients will receive spinal block at lumbar 3-4 or 4-5
intervertebral space with an injection of the pre-prepared local anesthetic mixture according
to the group of patient. After giving anesthesia and positioning for surgery with a left
lateral tilt of 15 degrees, supplemental oxygen at a rate of 4 liters/minute will be applied.