| 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
|
|
|
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
|
|
|
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. |