G.I.T. Motility After General Versus Spinal AnaesthesiaPhase 4NCT02504749
The Regain of Gastrointestinal Motility After General Anaesthesia Versus Spinal Anaesthesia in Caesarean Section
A Phase 4 study testing general anasthesia,spinal anasthesia in people with G.I.T. Motility After General Versus Spinal Anaesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- G.I.T. Motility After General Versus Spinal Anaesthesia
- What is being tested?
- general anasthesia,spinal anasthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients set for planned cesarean section under general or spinal anesthesia:
- age from 18 to 37 years.
- Full term(37-41 weeks).
- Singleton pregnancy.
- Hemoglobin level more than 11 gm/dl.
Who cannot join
- Contraindication to regional anesthesia i.e(patient refusal,coagulopathy,significant hypovolemia,systemic or local sepsis,increased intracranial pressure,severe stenotic valvular heart disease,pre existing neurologic conditions and local anesthetic or fentanyl allergy.
- High risk pregnancies as pre eclampsia,eclampsia,any medical disorder(DM,cardiac and thyroid diseases).
- Previous intestinal surgery,previous C.S. and previous gynecological operations.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Abdel Aziz El Sharkawy
Cairo, 12345
Mohamed El Sharkawy, Md, 00201221731328, kingdoc82@outlook.com
About this study
Official title: Randomised Study to Compare the Regain of Gastrointestinal Motility After General Anaesthesia Versus Spinal Anaesthesia in Caesarean Section.Kasr El Ainy,Egypt Experience
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.
Read the detailed description
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:
- Full name,age,telephone number and address.
- Past medical history of hypertension,diabetes and other endocrine diseases,also history of abdominal operations.
- Gravidity and parity.
- 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:
- Caesarean section done by senior resident.
- Skin opened by pfannensteil incision
- The abdomen opened in layers.
- The peritoneum opened by elevating it with two clamps placed 2 cm apart. It is incised sharply superiorly to the upper pole of the incision and downward to just above bladder reflection.
- The lower peritoneal flap elevated and gentle blunt bladder dissection done.
- Transverse incision of the lower uterine segment.
- The baby is delivered:a hand is slipped into the uterine cavity between the symphysis and fetal head.Head elevation with the fingers and palm through the incision.
- Intravenous infusion containing 20 units of oxytocin after shoulder delivery.
- Spontaneous placental delivery.
- Closure of uterine incision in two layers using blunt needle and absorbable continuous Vicryl 1 sutures (Ethicon; Somerville,New Jersey,, USA) in a continuous double layer.
- Closure of visceral and parietal peritoneum by continuous absorbable suture Vicryl 2-0.
- Rectus sheath sutured using continuous absorbable suture Vicryl 1 sutures.
- In all patients, the fascia was closed with continuous Vicryl 1 sutures, subcutaneous fat was closed with interrupted Vicryl 2-0 sutures, and the skin was closed with subcuticular Prolene 2-0 sutures (Ethicon).
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:
- close observation for vital data,vaginal bleeding and urine output.
- The same hospital fluid regimen with 500 ml of 5 % glucose every 6 hours,500 ml of ringer every 12 hours and 500 ml saline every 24 hours.
- Postoperatively, all patients were given 75 mg diclofenac sodium (Voltaren; Novartis,Cairo, Egypt) as intravenous infusion in dextrose, followed by 50 mg diclofenac potassium (Cataflam; Novartis) orally every 8 hours for pain relief.
- No oral or rectal bowel stimulants were given after surgery.
- Auscultation of intestinal sounds started two hours after operation and was performed at one hour interval till normal bowel sounds were detected.
- The patients allowed to sip small amount of water only 12 hours postoperatively.
- The oral intake of clear fluid and soft food was allowed when normal bowel sounds were detected and flatus has passed with advancement to regular diet after passage of first bowel motion.
- Clinically significant ileus was considered with appearance of group of manifestations(persisting more than 24 hours or requiring nasogastric tube placement) which include absent or hypo active bowel sounds,abdominal distension and more than three episodes of vomiting with or without crampy abdominal pain.
- Eligible criteria for hospital discharge included:stable vital signs with no febrile morbidity for at least 24 hours,ability to ambulate and to urinate without assistance,passage of bowel motion,ability to tolerate solid food without emesis and absence of unresolved other postoperative complications.
The main outcome measures are:
- Case number
- Age
- Parity
- Gestational age
- Body mass index.
- Duration of surgery.
- Time of 1 st intestinal sound
- Time of 1 st flatus.
- Time of 1 st motion
- Duration of hospital stay.
- Post operative fever,distension or ileus.
- Opioid and Non steroidal anti-inflammatory use.
- Being tested
- general anasthesia,spinal anasthesia
- Keywords
- GIT motility, General anaesthesia, spinal anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anasthesia,spinal anasthesiaProcedure or surgery
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: general anasthesia,spinal anasthesia |
| 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. Receives: Procedure: general anasthesia,spinal anasthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first flatus
Measured: 3 months
Secondary outcomes (1)
postoperative complications
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for G.I.T. Motility After General Versus Spinal AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El-Sharkawy, Kasr El Aini Hospital
- Investigators
- Kasr El Ainy, Study chair, Office Dean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504749
- Sponsor's protocol ID
- KasrELAini
- Status last verified
- Jul 2015
- First submitted
- 18 Jul 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study to Compare the Regain of Gastrointestinal Motility After General Anaesthesia Versus Spinal Anaesthesia in Caesarean Section.Kasr El Ainy,Egypt Experience
- ClinicalTrials.gov ID
- NCT02504749
- Acronym / sponsor ID
- KasrELAini
- Keywords
- GIT motility, General anaesthesia, spinal anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Full name,age,telephone number and address.
- Past medical history of hypertension,diabetes and other endocrine diseases,also history of abdominal operations.
- Gravidity and parity.
- 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:
- Caesarean section done by senior resident.
- Skin opened by pfannensteil incision
- The abdomen opened in layers.
- The peritoneum opened by elevating it with two clamps placed 2 cm apart. It is incised sharply superiorly to the upper pole of the incision and downward to just above bladder reflection.
- The lower peritoneal flap elevated and gentle blunt bladder dissection done.
- Transverse incision of the lower uterine segment.
- The baby is delivered:a hand is slipped into the uterine cavity between the symphysis and fetal head.Head elevation with the fingers and palm through the incision.
- Intravenous infusion containing 20 units of oxytocin after shoulder delivery.
- Spontaneous placental delivery.
- Closure of uterine incision in two layers using blunt needle and absorbable continuous Vicryl 1 sutures (Ethicon; Somerville,New Jersey,, USA) in a continuous double layer.
- Closure of visceral and parietal peritoneum by continuous absorbable suture Vicryl 2-0.
- Rectus sheath sutured using continuous absorbable suture Vicryl 1 sutures.
- In all patients, the fascia was closed with continuous Vicryl 1 sutures, subcutaneous fat was closed with interrupted Vicryl 2-0 sutures, and the skin was closed with subcuticular Prolene 2-0 sutures (Ethicon).
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:
- close observation for vital data,vaginal bleeding and urine output.
- The same hospital fluid regimen with 500 ml of 5 % glucose every 6 hours,500 ml of ringer every 12 hours and 500 ml saline every 24 hours.
- Postoperatively, all patients were given 75 mg diclofenac sodium (Voltaren; Novartis,Cairo, Egypt) as intravenous infusion in dextrose, followed by 50 mg diclofenac potassium (Cataflam; Novartis) orally every 8 hours for pain relief.
- No oral or rectal bowel stimulants were given after surgery.
- Auscultation of intestinal sounds started two hours after operation and was performed at one hour interval till normal bowel sounds were detected.
- The patients allowed to sip small amount of water only 12 hours postoperatively.
- The oral intake of clear fluid and soft food was allowed when normal bowel sounds were detected and flatus has passed with advancement to regular diet after passage of first bowel motion.
- Clinically significant ileus was considered with appearance of group of manifestations(persisting more than 24 hours or requiring nasogastric tube placement) which include absent or hypo active bowel sounds,abdominal distension and more than three episodes of vomiting with or without crampy abdominal pain.
- Eligible criteria for hospital discharge included:stable vital signs with no febrile morbidity for at least 24 hours,ability to ambulate and to urinate without assistance,passage of bowel motion,ability to tolerate solid food without emesis and absence of unresolved other postoperative complications.
The main outcome measures are:
- Case number
- Age
- Parity
- Gestational age
- Body mass index.
- Duration of surgery.
- Time of 1 st intestinal sound
- Time of 1 st flatus.
- Time of 1 st motion
- Duration of hospital stay.
- Post operative fever,distension or ileus.
- Opioid and Non steroidal anti-inflammatory use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: General anaesthesia group | Active comparator | Procedure: general anasthesia,spinal anasthesia-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 | Procedure: general anasthesia,spinal anasthesiaPrehydration 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients set for planned cesarean section under general or spinal anesthesia:
Key exclusion criteria (3 listed)
- Contraindication to regional anesthesia i.e(patient refusal,coagulopathy,significant hypovolemia,systemic or local sepsis,increased intracranial pressure,severe stenotic valvular heart disease,pre existing neurologic conditions and local anesthetic or fentanyl allergy.
- High risk pregnancies as pre eclampsia,eclampsia,any medical disorder(DM,cardiac and thyroid diseases).
- Previous intestinal surgery,previous C.S. and previous gynecological operations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anasthesia,spinal anasthesiaRandomization 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 . | Procedure or surgery | Group A: General anaesthesia group, Group B:Spinal anaesthesia group. |
Primary outcome
Time of first flatus
Time frame: 3 months
1 secondary outcome
postoperative complications
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasr El Ainy study chair
Office Dean
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing general anasthesia,spinal anasthesia in people with G.I.T. Motility After General Versus Spinal Anaesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ab El Sharkawy, M.D. (00201221731328, kingdoc82@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of first flatus (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.