FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081250 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of pre surgery carbohydrate drink on the occurrence of decrease in blood pressure after spinal anesthesia in elderly patients undergoing prostate surgery  
Scientific Title of Study   Effect of pre surgery carbohydrate drink on the incidence of post spinal hypotension in elderly patients undergoing transurethral resection of prostate: A randomised control trial  
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 Swati Chhabra  
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Anaesthesiology and Critical Care Third floor Emergency block AIIMS Basni industrial area phase 2 Jodhpur RAJASTHAN 342005 India

Jodhpur
RAJASTHAN
342001
India 
Phone  07340033034  
Fax    
Email  swati_virgo83@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Chhabra  
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Anaesthesiology and Critical Care Third floor Emergency block AIIMS Basni industrial area phase 2 Jodhpur RAJASTHAN 342005 India

Jodhpur
RAJASTHAN
342001
India 
Phone  07340033034  
Fax    
Email  swati_virgo83@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gauri Mehta 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Anaesthesiology and Critical care, Third floor Emergency block AIIMS Basni industrial area phase 2 Jodhpur RAJASTHAN 342005 India

Jodhpur
RAJASTHAN
340021
India 
Phone  9980779673  
Fax    
Email  drgaurimehta@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences Jodhpur, Basni phase 2, 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur  
Address  Basni industrial area phase 2 Jodhpur Rajasthan 342005  
Type of Sponsor  Research institution and hospital 
 
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 Swati Chhabra  All India Institute of Medical Sciences Jodhpur   Department of Anaesthesiology and Critical Care, Third floor, D & T Block, AIIMS, Basni Phase 2, Jodhpur 342005
Jodhpur
RAJASTHAN 
07340033034

swati_virgo83@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, JODHPUR, Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional NPO guidelines   Patients advised to follow conventional fasting guidelines of 6 hours for solids and 2 hours for clear liquids before elective surgery 
Intervention  Preoperative administration of carbohydrate drink  Oral administration of premixed carbohydrate drink of 296 ml (one bottle), once, up to two hours prior to scheduled time of surgery.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  Adult males (60-90 years), ASA 1, 2 undergoing elective Transurethral Resection of Prostate under Spinal Anaesthesia
 
 
ExclusionCriteria 
Details  1. Patients belonging to ASA 3,4
2. Patients with Diabetes Mellitus
3. Patients with Hypertension and on treatment with diuretics
4. Patients with Gastric motility disorders like GERD
5. Patients with Opioid use
6. Patients with known cardiac disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of incidence of postspinal hypotension in patients undergoing TURP with pre surgery carbohydrate loading and conventional fasting guidelines.   Within 20 minutes of Spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To compare patient discomfort due to hunger and/or thirst in patients undergoing TURP under spinal anesthesia with pre surgery carbohydrate loading & conventional fasting guidelines.
 
T0 Before administering carbohydrate drink
T1 At the time of shifting the patient to the operating room
T(PACU) When in Post Anaesthesia Care Unit  
To compare perioperative blood glucose levels with pre surgery carbohydrate loading & conventional fasting guidelines.
 
T0 Before administering carbohydrate drink
T1 At the time of shifting the patient to OT
T2 One hour after T1
T3 One hour after T2 
To compare postoperative nausea & vomiting
 
T(PACU) - When shifted to Post Anaesthesia Care Unit (PACU)
TPO1, TPO2, TPO3, TPO3, TPO4,TPO6, TP012, TPO24 which denote 1,2,4,6,12,24 hours postoperatively respectively 
To evaluate the mean fasting duration of patients advised to follow conventional fasting guidelines.
 
For Intervention group: From oral intake to T0
For Comparator Group : From oral intake to T1  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   10/03/2025 
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="6"
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  

Preoperative fasting guidelines are a necessary component of surgical preparation of the patient. The American Society of Anesthesiologists (ASA) have conventionally recommended a period of fasting of 6 hours for light meals and 2 hours for clear liquids for adults undergoing elective surgeries. Adequate fasting periods are required to prevent adverse intra operative complications like pulmonary aspiration of gastric contents. In recent times, adaptability to the said fasting periods have been proposed with an aim to reduce prolonged fasting. Long hours of fasting preoperatively can lead to dehydration, patient discomfort and increased catabolic response to surgery. A modular update of The Practice guidelines for preoperative fasting periods were introduced by the ASA in 2017 that focused on reducing unnecessary prolonged fasting periods along with the use of pre surgery carbohydrate drinks.  

Additionally, post spinal induction hemodynamic instability intraoperatively has been known to occur significantly more in the elderly age group. The incidence of spinal induced hypotension increases up till 75% in age group over 5o years of age as opposed to 36% incidence in younger age groups.

Therefore, with the use of of pre-surgical carbohydrate loading as per the Modular ASA guidelines, we aim to evaluate the incidence of and measure intraoperative hypotension occurring in elderly age groups consuming pre surgery carbohydrate loading among patients posted for elective Transurethral Resection of Prostate (TURP) under spinal anesthesia and contrast this with another matched cohort following conventional preoperative fasting advice. It will be a Randomized controlled trial, single blinded study.
In conjecture to this we aim to hypothesise the mean duration of preoperative fasting that the latter group of patients follow as per conventional nil per oral fasting guidelines in our institute. 

 
Close