| CTRI Number |
CTRI/2025/11/097582 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to see whether giving water to patients soon after surgery helps reduce thirst and improves comfort |
|
Scientific Title of Study
|
Effect of early postoperative oral hydration
on thirst, comfort and metabolic stress markers following regional anaesthesia: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Manisha Manohar |
| Designation |
Associate Professor |
| Affiliation |
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9650195959 |
| Fax |
|
| Email |
manishamb123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vrinda Arora |
| Designation |
Junior Resident |
| Affiliation |
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences |
| Address |
epartment of Anaesthesiology and Critical Care
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
07289023873 |
| Fax |
|
| Email |
vrinda.arora09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vrinda Arora |
| Designation |
Junior Resident |
| Affiliation |
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
07289023873 |
| Fax |
|
| Email |
vrinda.arora09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana,India 124001 |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma Postgraduate Institute of Medical Sciences |
| Address |
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India 124001 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha Manohar |
Pt. B. D. Sharma, PGIMS |
Department of Anaesthesiology and Critical Care, Modular OT complex, 2nd floor, room 20
Rohtak
HARYANA |
9650195951
Manishamb123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
carbohydrate drink |
Eligible patients will be identified during the pre-anaesthesia assessment. Detailed information about the study will be provided and written informed consent will be obtained at least one day prior to surgery. All patients will follow the standard institutional fasting guidelines. Following elective non-gastrointestinal surgery performed under regional anaesthesia, patients will be transferred to the Post-Anaesthesia Care Unit (PACU) for postoperative monitoring.At 15 minutes postoperatively, patients in the early hydration group will be clinically assessed for readiness to initiate oral intake based on the following criteria:
1. Full recovery of consciousness (alert, oriented, able to state their name, and respond appropriately).
2. Stable vital signs (heart rate, blood pressure and oxygen saturation within acceptable ranges).
3. Presence of intact protective airway reflexes (cough and swallowing reflexes).
4. Willingness to drink fluids. Patients declining oral intake at the initial assessment will be monitored per standard care but excluded from the intervention analysis.
If the above criteria are met, the following protocol will be followed:
• Baseline thirst score 15 minutes post-operatively will be assessed.
• Baseline comfort score 15 minutes post-operatively will be assessed.
• An initial trial of 10 mL of room-temperature clear water will be offered using a graduated cup and straw.
• If well tolerated over the next 5 minutes, the patient will be offered clear carbohydrate rich drink (containing 169mg/mL of carbohydrate) which will be administered according to the following volume limits:
o 0–60 minutes (First postoperative hour): Up to 0.5 mL/kg body weight, sipped on demand.
o 60–120 minutes (Second postoperative hour): An additional 1.0 mL/kg body weight, based on continued tolerance and patient request.
|
| Comparator Agent |
Standard hydration |
The timing and type of oral fluid administration will follow standard practices routinely adopted by each unit. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients aged 18–60 years.
2 ASA physical status I–II.
3 Undergoing non gastrointestinal surgery under regional anaesthesia.
4 Able to provide informed consent and understand instructions.
|
|
| ExclusionCriteria |
| Details |
1 Patients refusing to participate.
2 Patients with diabetes mellitus.
3 Known adrenal or endocrine disorders, dyselectrolytemia in last 48 hours.
4 Gastrointestinal surgery or contraindication to early oral intake.
5 Intraoperative conversion to general anaesthesia.
6 Prolonged sedation or delayed recovery.
7 History of nausea vomiting or antiemetic use in the last 24 hours.
8 Intraoperative use of antiemetics and steroids.
9Communication barriers or cognitive dysfunction.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in postoperative thirst intensity between the early hydration and standard delayed hydration groups using visual analog scale (VAS). |
TB - Baseline (15 minutes after shift to PACU)
T0 - Immediately after first intake of 10 ml water
T1 - 1 hour after first intake
T2 - 2 hours after first intake
T6 – 6 hours after first intake
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare subjective comfort using visual analog scale (VAS). |
TB - Baseline (15 minutes after shift to PACU)
T0 - Immediately after first intake of 10 ml water
T1 - 1 hour after first intake
T2 - 2 hours after first intake
T6 – 6 hours after first intake
|
| 2. To compare serum cortisol concentrations at 6 hours post-operatively as an indicator of perioperative stress response. |
T6 – 6 hours after first intake
|
| 3. To compare blood glucose levels between early and standard delayed hydration groups to assess metabolic response to early hydration. |
TB - Baseline (15 minutes after shift to PACU)
T6 – 6 hours after first intake |
| 4. To compare the timing of initiation and tolerance of oral feeding in both the groups. |
TB - Baseline (15 minutes after shift to PACU)
T0 - Immediately after first intake of 10 ml water
T1 - 1 hour after first intake
T2 - 2 hours after first intake
T6 – 6 hours after first intake
|
| 5. To compare the incidence of post-operative nausea and vomiting. |
T1 - 1 hour after first intake
T2 - 2 hours after first intake
T6 – 6 hours after first intake
|
|
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
14/12/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is to evaluate whether early oral intake of
clear fluids, initiated within two hours of surgery under regional anesthesia,
is safe and effective in improving patient comfort and modulating postoperative
stress markers.
|