| CTRI Number |
CTRI/2024/04/066555 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
The effect of preoperative fasting time on the incidence of spinal anaesthesia related low blood pressure among adult patients scheduled for elective surgeries |
|
Scientific Title of Study
|
The impact of preoperative fasting duration on the incidence of spinal anaesthesia induced hypotension among adult patients scheduled for elective surgery: A prospective observational study |
| 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 SowjanyaH |
| Designation |
Post graduation(MD), Anaesthesiology and critical care medicine |
| Affiliation |
Sri Venkateswara Institute of medical sciences(SVIMS) |
| Address |
Department of Anaesthesiology, SVIMS, Alipiri road, Tirupati, Chittoor district, Andhra Pradesh.517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9959861389 |
| Fax |
|
| Email |
h.sowjanya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and HOD, Department of Anaesthesiology and critical care medicine, SVIMS |
| Affiliation |
Sri Venkateswara Institute of medical sciences(SVIMS) |
| Address |
Department of Anaesthesiology, SVIMS, Alipiri road, Tirupati, Chittoor district, Andhra Pradesh.517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and HOD, Department of Anaesthesiology and critical care medicine, SVIMS |
| Affiliation |
Sri Venkateswara Institute of medical sciences(SVIMS) |
| Address |
Department of Anaesthesiology, SVIMS, Alipiri road, Tirupati, Chittoor district, Andhra Pradesh.517507
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Alipiri raod, Tirupati, Chittoor district, Andhra Pradesh 517507 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Sowjanya H |
Sri Venkateswara Institute of medical sciences |
Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati, Chittoor district, Andhra Pradesh 517507
Chittoor
ANDHRA PRADESH |
9959861389
h.sowjanya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SVIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a recorded time of last clear fluid intake on the day of surgery. ASA physical status I & II |
|
| ExclusionCriteria |
| Details |
1. ASA PS III and above
2. Preoperative heart rate less than 45 beats/minute
3. Preoperative mean arterial blood pressure less than 65 mmHg
4. Obesity with BMI more than 30
5. Height less than 150 cm and more than 180 cm 6. Weight less than 50 kg and more than 80 kg
7. Patients with cardiac arrhythmia, or on rate/vascular tone modulation therapy
8. Patients who received intravenous fluid administration during the preanaesthesia fasting period
9. Pregnant women and lactating mothers
10. Patients unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the preoperative fasting duration specific effect on incidences of low systolic blood pressure in the early phase (0-5 min) and secondary phase (6-30 min) after Spinal anaesthesia induction. |
Early phase (0-5 min)
Secondary phase (6-30 min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the association between clear fluids fasting duration and the incidence of low blood pressure
To observe any association between clear fluids fasting duration and occurrence of Nausea, vomiting, shivering, discomfort, allergic reaction, or any other complications
|
Initial 5 to 30 mins |
|
|
Target Sample Size
|
Total Sample Size="363"
Sample Size from India="363"
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)
|
01/05/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [h.sowjanya@gmail.com].
- For how long will this data be available start date provided 01-05-2024 and end date provided 01-05-2054?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Preoperative fasting for certain hours is an established practice across the globe to reduce the risk of pulmonary aspiration of gastric contents.
Most of the societies including Indian society of Anaesthesiologists recommend 6-8hrs of nil by mouth for solid and permits consumption of clear fluid up to 2hrs before surgery. However, considering the different types of health care facility in India and adoption to regional cultural practice the actual fasting time for bothe solids and liquids vary widely and may well exceed the expected 6-8 hrs particularly if the case is not scheduled as first case in the list. Consensus guidelines regarding the optimal fasting duration lack robust evidence across a broad range of ages and surgeries. We hypothesized that different duration of fasting before scheduled surgery would expose the patient to variable degree of hemodynamic consequences like low blood pressure.
The current study is designed to determine the influence of duration of preoperative fasting on blood pressure in early phase (0-5 min) or secondary phase (10-15min) after spinal anaesthesia induction. |