| CTRI Number |
CTRI/2024/07/070904 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare general anaesthesia versus spinal anaesthesia in patients undergoing bladder hydrodistension for interstitial cystitis. |
|
Scientific Title of Study
|
A randomized prospective comparative clinical study of Hemodynamic responses during bladder hydrodistension under general versus spinal anaesthesia in patients with interstitial cystitis in department of anaesthesia, SMS Medical College, Jaipur |
| 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 Anupama Gupta |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Gupta |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College, Adarsh Nagar, Jaipur, Rajasthan
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archie Sharma |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7426985486 |
| Fax |
|
| Email |
sharmaarchie2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and attached hospitals, JLN Marg, Adarsh Nagar, Jaipur- 302004, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology SMS Medical College And Attached Hospitals |
| Address |
JLN Marg, Adarsh Nagar, Jaipur-302004, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Archie Sharma |
Sawai Man Singh Medical College And Attached Hospitals |
Urology operation theatre, 7th floor, Super Specialty Building, Sawai Man Singh Medical College And Attached Hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
7426985486
sharmaarchie2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of Ethics Committee, SMS Medical College and attached hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N301||Interstitial cystitis (chronic), (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General Anaesthesia |
Patient will be induced 5 minutes prior the bladder hydrodistension with propofol in the dose of 2mg/kg after giving premedication which are inj. midazolam (0.05mg/kg), inj. glycopyrolate (0.005mg/kg), inj. fentanyl (2mcg/kg). Supraglottic airway device of appropriate size will be inserted after giving proper muscle relaxant to the patient and hemodynamic changes will be monitored. Reversal of the patient will be done after completion of the procedure and patient will be kept in PACU for 15 minutes after the procedure. |
| Comparator Agent |
Spinal Anaesthesia |
Prior to bladder hydrodistension patient is painted and draped under aseptic precautions and sub-arachnoid block will be given in L3-L4 space using 25G Quinckies needle after confirming clear free flow of CSF. Desired effect will be checked and procedure will start after 5 minutes of spinal anaesthesia. Hemodynamic changes will be monitored intraoperatively and will be kept in PACU for 15 minutes after completion of the procedure. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective bladder hydrodistension.2. Patients willing to give informed consent. American Society of Anaesthesiologist physical status I-III. |
|
| ExclusionCriteria |
| Details |
1.Patient should not be part of any other study.2.Un-cooperative patient.3.Patient who is allergic to any drug of general or spinal anaesthesia.4.Patient who is on anticoagulants.5.Patients with raised intra cranial pressure.6.Patients with severe cardiovascular diseases.7.Patients with spinal deformity or local site infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and compare the maximum increase in heart rate, mean arterial pressure, systolic blood pressure and diastolic blood pressure during bladder hydrodistension from baseline in general versus spinal anaesthesia. |
To determine and compare the maximum increase in heart rate, mean arterial pressure, systolic blood pressure and diastolic blood pressure at baseline, 2 minutes after induction, 5 minutes, 15 minutes, 25 minutes, 35 minutes and 45 minutes during bladder hydrodistension from baseline in general versus spinal anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate post-operative pain using NRS pain score during their stay in post anaesthesia care unit (PACU). |
30 minutes after completion of procedure. |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Interstitial cystitis , a disease of lower urinary presents with symptoms of chronic bladder pain and increased urinary frequency which results in impaired quality of life of patients. The diagnosis of interstitial cystitis is difficult to make as well as the disease is difficult to treat. Bladder hydrodistension is not only a diagnostic tool but also a treatment option for the patients of interstitial cystitis. patients who are undergoing bladder hydrodistension show a marked autonomic response during the procedure resulting in increase in heart rate and blood pressure . Thus blocking the abrupt increase in blood pressure and heart rate associated with autonomic response during bladder hydrodistension in patients with interstitial cystitis is essential for patients safety. Hence, we have designed this study to compare hemodynamic responses during bladder hydrodistension in patients with interstitial cystitis under general versus spinal anaesthesia. So that appropriate anaesthetic procedure can be used for patient’s safety during surgical procedure. |