| CTRI Number |
CTRI/2018/04/013502 [Registered on: 26/04/2018] Trial Registered Prospectively |
| Last Modified On: |
22/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Other (Specify) [clear oral fluids] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of unrestricted clear oral fluids two to three hours before spinal anaesthesia on intraoperative heart rate and blood pressure and recovery after surgery |
|
Scientific Title of Study
|
Effect of unrestricted clear oral fluids two to three hours before spinal anaesthesia on intraoperative hemodynamics and recovery profile |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nihal Muhammed |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Junior Resident, Department of Anaesthesiology and Intensive Care, PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9995427637 |
| Fax |
|
| Email |
nihal.29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ishwar Bhukal |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Professor, Department of Anaesthesiology and Intensive Care, PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009535 |
| Fax |
|
| Email |
ishwar_bhukal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nihal Muhammed |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Junior Resident, Department of Anaesthesiology and Intensive Care, PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9995427637 |
| Fax |
|
| Email |
nihal.29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
Nihal Muhammed |
| Address |
Junior Resident, Department of Anaesthesiology and Intensive Care, PGIMER, Chandigarh, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ishwar Bhukal |
Professor, Department of Anaesthesiology and Intensive Care, PGIMER, Chandigarh, India |
| Kamal Kajal |
Assistant Professor, Department of Anaesthesiology and Intensive Care, PGIMER, Chandigarh, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nihal Muhammed |
Postgraduate Institute of Medical Education and Research |
Main Operation Theatre Complex, Department of Anaesthesiology and Intensive Care, Level 4, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH |
9995427637
nihal.29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA physical status 1 and 2 patients undergoing surgery requiring spinal anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Study group) |
Patients allocated are advised to drink unrestricted amount of water so as to quench their thirst 2 to 3 hours before the expected shifting time to the operating room |
| Comparator Agent |
Group B (Control group) |
Patients allocated are allowed to follow the routine fasting practices |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA class 1 and 2
2. Age 18 to 65 years
3. Procedures under spinal anaesthesia with duration of 2 hours or less
4. Procedures with minimal blood loss not requiring blood transfusion |
|
| ExclusionCriteria |
| Details |
1. Contraindication to spinal anaesthesia
2. Posted for gastrointestinal surgery
3. Active gastroesophageal reflux disease
4. Psychiatric patients
5. Patients in whom delayed gastric emptying is suspected |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on hemodynamics (heart rate, mean arterial pressure) and fluid and vasopressor requirement |
Intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on anxiety scoring |
Preoperative and postoperative period |
| Effect on thirst scoring |
Preoperative and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2018 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Though standard guidelines are available for preoperative fasting, due to various reasons like improper communication by the personnel or understanding by patients, delays in the setup or mere ignorance, or being posted down the order in an operating list, very often patients fast for a longer undesirable time. This effects the overall perioperative experience of the patient. The aim of this study is to study the effect of unrestricted clear oral fluids two to three hours before spinal anaesthesia on the intraoperative hemodynamics and recovery profile, which includes the intraoperative heart rate and mean arterial pressures, fluid and vasopressor requirement and the preoperative and postoperative anxiety and thirst scoring. |