FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070892 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oral rehydration 2 hours before surgery]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety of taking oral clear drinks 2 hours before scheduled caesarean section by measuring stomach volume through ultrasound in pregnant women  
Scientific Title of Study   Assessing the Safety of Preoperative oral Rehydration Prior to Cesarean Delivery by Ultrasound Evaluation of Gastric Volume 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Jarathi 
Designation  Assistant Professor 
Affiliation  AIIMS,Bibinagar 
Address  Department of Obstetrics and Gynaecology, AIIMS Bibinagar, Bhongir district, Hyderabad

Nalgonda
TELANGANA
508126
India 
Phone  8106732587  
Fax    
Email  draparnaj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aparna Jarathi 
Designation  Assistant Professor 
Affiliation  AIIMS,Bibinagar 
Address  Department of Obstetrics and Gynaecology, AIIMS Bibinagar, Bhongir district, Hyderabad

Nalgonda
TELANGANA
508126
India 
Phone  8106732587  
Fax    
Email  draparnaj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aparna Jarathi 
Designation  Assistant Professor 
Affiliation  AIIMS,Bibinagar 
Address  Department of Obstetrics and Gynaecology, AIIMS Bibinagar, Bhongir district, Hyderabad

Nalgonda
TELANGANA
508126
India 
Phone  8106732587  
Fax    
Email  draparnaj@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bibinagar Hyderabad TELANGANA 508126 India  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Bibinagar 
Address  All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region, Telangana 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aparna J  All India Institute of Medical Sciences, Bibinagar  Room numbers G35 and G36, Operation Theater Complex
Nalgonda
TELANGANA 
8106732587

draparnaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  clear fluids   permitting light meal until 6 hours and to clear fluids and water until 2 hours before caesarean surgery 
Comparator Agent  fasting   Permitting light meal until 8 hours and to clear fluids and water until 6 hours before caeserean surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  age ≥ 18 years, singleton gestation at term (37–42 weeks), uncomplicated pregnancy, patients scheduled for an elective cesarean delivery, planned for spinal anaesthesia. 
 
ExclusionCriteria 
Details  preexisting diabetes (gestational diabetes, type I DM, type II DM), gastro-intestinal reflux (GERD), pre-pregnancy BMI more than 40, unable or unwilling to sign an informed consent, contraindications to spinal anaesthesia, contraindication to oral carbohydrate formula, patients on intravenous fluid therapy, hypertensive disorders of pregnancy, heart disease, liver, gastrointestinal disorders, placenta accrete spectrum, complications developed during intraoperative, postoperative period, prolonged surgery time due to intraoperative complications 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of preoperative oral rehydration by measuring the gastric volume by ultrasound in pregnant women undergoing elective caesarean surgery  30 minutes before scheduled surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate, BP, SpO2, the need for supplemental analgesics, and the occurrence of certain side effects (nausea, vomiting, hypotension episodes, and treatment required) will be recorded intraoperatively and at four-hour intervals throughout the first 24 hours postoperatively.   During surgery and every 4th hour until first 24 hours after surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After obtaining IEC approval and informed consent, all the eligible patients will be recruited for the study. It will be an open label, a non-blinded, randomised controlled study. The study participants will be randomly allocated into the two groups (Group A, Group B). Randomization is done by computer-generated software (www.randomizer.org). The randomization sequence will be generated using random number generator. The random allocation sequence will be placed in sealed numbered opaque envelopes for strict number order assignment to participants. Participants randomized to Group A will be permitted light meal until 6 hours and to clear fluids and water until 2 hours before surgery. Participants randomized to Group B will be permitted light meal until 8 hours and to clear fluids and water until 6 hours before surgery.

Clear fluids can be (water, oral rehydration solution (dextrose approx. 75 gm in 200 ml), sucrose solution (approx. 35 grams, four teaspoons of the powder Glucon D, to 200 ml of water), black tea/coffee or coconut water) will be given freely until 2 hours before scheduled caesarean surgery to Group A. The total amount of preoperative clear fluids intake will be recorded for 6 hours before surgery in Group A. The amount of fluid intake taken will be as per the patient’s thirst, choice and tolerance.

The operating theater staff would call for patients to be sent to the obstetric operating theater from the antenatal ward 15-30 minutes before expected entry into the operating theater for commencement of spinal anesthesia, bladder catheterization, and immediate follow-on cesarean section. Patients will be kept at reception bay of the recovery area if the operating theater is not immediately available.

Demographic data and clinical characteristics, such as age, weight, body mass index (BMI), gestational age, parity, previous C-section, fasting time, and time and type of food taken as last diet, in both the groups will be recorded on arrival to the operating room. Abdominal ultrasonography will be performed in the sagittal or para-sagittal plain in the right lateral decubitus position. Sonographic landmarks such as the liver, aorta, vena cava, and pancreas, as well as the classical appearance of the gastric antrum, will be used in sonography to identify the antrum in the scanning area. The probe will be tilted as needed to ensure a proper transverse view of the antrum, avoiding oblique images that may have resulted in an overestimation of the cross-sectional area of the antrum. Three consecutive still images will be obtained, labelled, and stored. The two antral diameters will be measured from serosa to serosa (7). All images will be obtained with the antrum at rest, not during peristaltic contractions. The cross-sectional area (CSA) of the antrum will be calculated according to the formula described by Bolondi et al. (8) using two maximum perpendicular diameters representing the surface area of an ellipse, as follows: CSA = AP × CC × π/4 (AP, anteroposterior diameter; CC, craniocaudal diameter). The mean of the three measurements will be used as the CSA value. Measurement of the antral area will be performed by an anesthesiologist or obstetrician skilled in image acquisition and identification (experience of using ultrasound for > 2 years) of the gastric antrum by using a curvilinear array, low frequency (2 to 5 MHz) transducer of Sonosite Edge II Ultrasound Machine.

Before surgery, an intravenous line will be established on the non-dominant hand using 18 G size intravenous cannula. The multi-channel monitor will be attached, and baseline parameters of pulse rate, blood pressure (systolic, diastolic, and mean), electrocardiography (lead II, V) and SpO2 will be recorded. Under aseptic precautions, with the patient in a sitting/lateral position, the subarachnoid blocks will be performed at L3-L4 or L4-L5 intervertebral spaces and will receive 10 mg of intrathecal Hyperbaric Levobupivacaine (0.5%) or bupivacaine (0.5%).

Vasopressors will be administered when the systolic blood pressure falls below 90 mmHg or decreased by > 20% of the baseline value. As a vasopressor, phenylephrine (50 mcg) will be administered for hypotension with HR ≥ 60 beats/min or ephedrine (5 mg) for hypotension with HR < 60 beats/min. We will count the administration of 100 mcg of phenylephrine or 5 mg ephedrine as one dose. After birth, oxytocin (05-15 units) diluted in ringer’s lactate will be administered to stimulate uterine contraction. During surgery and every 8 hrs after surgery for 24 hrs, all patients will be given paracetamol 1000 mg IV  8th hourly. After surgery, all patients will be shifted to PACU (post anaesthetic care unit). Patients will be shifted from PACU after completing 9 points in the modified Aldrete post-anaesthetic recovery scale. If a patient requests additional analgesia (VAS ≥3), they will be treated with slow IV infusion of inj. Tramadol hydrochloride (50 mg) and or IV ketorolac 30 mg. For nausea and vomiting episodes, ondansetron (4 mg) will be prescribed.

The following outcome measures will be evaluated

The cross-sectional area of the gastric antrum will be measured upon arrival at the operation theatre. Heart rate, BP, SpO2, the need for supplemental analgesics, and the occurrence of certain side effects (nausea, vomiting, hypotension episodes, and treatment required) will be recorded intraoperatively and at four-hour intervals throughout the first 24 hours postoperatively.

 

Nausea and pruritus will be graded using a 4-point scale, where 0 = none, 1 = mild (requiring no treatment), 2 = moderate (responsive to treatment), and 3 = severe (unresponsive to ondansetron 8mg). Postoperative vomiting will be assessed using a different 4-point scale as follows: 0 = none, 1 = one to two episodes, 2 = 3 to 4 episodes, and 3 = more than 4 episodes. Before surgery, patients will be instructed about the use of the visual analogue scale (VAS; 0-10 cm), with 0 and 10 labelled as "no pain" and "worst pain imaginable," respectively. The VAS scores, nausea, vomiting and itching scores will be recorded at 3, 6, 12 and 24 hours after surgery for 24 hours. Time to pass flatus, time to return of bowel sounds, length of hospital stay, and maternal satisfaction (Likert Scales for thirst, hunger) will also be recorded.

Maternal and foetal side effects: Incidences of nausea or vomiting, hypotension, and medication need will be recorded perioperatively and up to 24 hours after surgery. Apgar scores for the neonates will be recorded at one and five minutes after delivery.

 
Close