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This study aims to compare the time to regain intestinal motility after general anesthesia versus spinal anesthesia for cesarean section.
A double blinded randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt, between July 20 and November 20, 2015. In the study hospital, the total number of deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.
The The study protocol was approved by the Scientific Research Committee of the department. Pregnant women with indication for caesarean section were enrolled after providing informed consent. It included 450 patients who had caesarean section and were subdivided into two groups according to a randomization scale.On the day of the operation,each randomly received a closed opaque envelope for the selection of the procedure(spinal versus general).
Patients were classified into two groups:
Group A: General anaesthesia group Group B:Spinal anaesthesia group.
All patients are subjected to the following:
Patients admitted from the outpatient clinic at Kasr El Ainy university Maternity Hospital.
Explanation of the procedure to all women participating in the study.
Informed written consent from every woman participating in this study.
Full history taking:
Examination:
1-Vital signs(pulse,blood pressure,temperature and respiratory rate). 2-Measurement of weight in kilograms,height in meters and calculation of body mass index.
6-Full laboratory investigations especially Complete blood count,liver functions,kidney functions,coagulation profile and random blood sugar.
7-Ultrasound assessment of fetal well being.
8-All women fasting for at least 8 hours prior to surgery.
General anaesthesia steps:
-Standard rapid sequence induction with pre-oxygenation by 100 % OXYGEN FOR 3 MINUTES FOLLOWED BY 4-5 mg/kg thiopental and 100 mg succinylcholine,cricoid pressure was applied once necessary.After correct placement of tracheal tube was confirmed,anaesthesia was maintained with up to 1.5% isoflurane and oxygen,neuromuscular blockade was maintained with 0.4 mg/kg atracurium.
Spinal anaesthesia steps:
Prehydration with 500 ml lactated ringer solution intravenous within 15 minutes in the sitting position.Low back was prepared and drapped in a sterile fashion with Betadine solution 10%.
Spinal anaesthesia performed at L 2-3 or L 3-4 intervertebral space using a fine needle size 22 G.Injection of local anaesthetics into the subarachnoid space,Bupivacaine(marcaine) 1.5 -3.5 ml used.
Operative data:
The data were recorded including presence of adhesions,application of intraperitoneal towels,estimated blood loss,operative time,time from start of caesarean section to fetal extraction and closure events.
After the end of surgery:
The main outcome measures are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: General anaesthesia group | Active Comparator | -Standard rapid sequence induction with pre-oxygenation by 100 % OXYGEN FOR 3 MINUTES FOLLOWED BY 4-5 mg/kg thiopental and 100 mg succinylcholine,cricoid pressure was applied once necessary.After correct placement of tracheal tube was confirmed,anaesthesia was maintained with up to 1.5% isoflurane and oxygen,neuromuscular blockade was maintained with 0.4 mg/kg atracurium. |
|
| Group B:Spinal anaesthesia group. | Active Comparator | Prehydration with 500 ml lactated ringer solution intravenous within 15 minutes in the sitting position.Low back was prepared and drapped in a sterile fashion with Betadine solution 10%. Spinal anaesthesia performed at L 2-3 or L 3-4 intervertebral space using a fine needle size 22 G.Injection of local anaesthetics into the subarachnoid space,Bupivacaine(marcaine) 1.5 -3.5 ml used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| general anasthesia,spinal anasthesia | Procedure | Randomization done by computer generated random number in sealed opaque envolopes.Each patient was given a study information sheet and a consent was signed. Sample size was calculated to prevent type II error. Based on these data, we would need to study 225 cases in each arm to be able to reject the null hypothesis that the rates for the experimental and control groups are equal with a probability of 80%. The type I error probability associated with this test for the null hypothesis is 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Additionally, to compensate for discontinuations, we recruited 225 women in each arm. 450-pregnant women with an indication for caesarean section were randomly allocated . |
| Measure | Description | Time Frame |
|---|---|---|
| Time of first flatus | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | 2 months |
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Inclusion Criteria:
Patients set for planned cesarean section under general or spinal anesthesia:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Ab El Sharkawy, M.D. | Contact | 00201221731328 | kingdoc82@outlook.com | |
| Waleed el Khayat, M.D. | Contact | 00201005135542 | waleed-elkhyat@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kasr El Ainy | Office Dean | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamed Abdel Aziz El Sharkawy | Recruiting | Cairo | 12345 | Egypt |
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