| CTRI Number |
CTRI/2024/06/069636 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare combination of general anaesthesia and spinal anaesthesia with general anaesthesia only in patients undergoing laproscopic gynaecological procedures |
|
Scientific Title of Study
|
Comparison between combined spinal and general anaesthesia versus general anaesthesia alone for laproscopicgynaecological procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragya pramanik |
| Designation |
Junior resident |
| Affiliation |
Dr.D.Y. Patil Medical College , Hospital and Rsearch Centre |
| Address |
Department of Anaesthesia ,5th Floor,Hi-tech building ,Dr. D.Y.Patil Medical College,Hospital and Rsearch Centre , Sant Tukaram Nagar,Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
8884181748 |
| Fax |
|
| Email |
goodheartpragya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor , Department of Anaesthesiology |
| Affiliation |
Dr.D.Y. Patil Medical College , Hospital and Rsearch Centre |
| Address |
Department of Anaesthesia ,5th Floor,Hi-techDe building ,Dr. D.Y.Patil Medical College,Hospital and Rsearch Centre , Sant Tukaram Nagar,Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor , Department of Anaesthesiology |
| Affiliation |
Dr.D.Y. Patil Medical College , Hospital and Rsearch Centre |
| Address |
Department of Anaesthesia ,5th Floor,Hi-techDe building ,Dr. D.Y.Patil Medical College,Hospital and Rsearch Centre , Sant Tukaram Nagar,Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi tech building ,Dr.D.Y.Patil
Medical College,Hospital and
Research Centre, Sant tukaram nagar,Pimpri, pune ,maharashtra ,india pincode-411018 |
|
|
Primary Sponsor
|
| Name |
Pragya pramanik |
| Address |
Department of Anaesthesia ,5th Floor,Hi-tech building ,Dr. D.Y.Patil Medical College,Hospital and Reseach Centre , Sant Tukaram
Nagar,Pimpri, pune ,maharashtra ,india pincode-411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 pragya pramanik |
Dr .D.Y.Patil Hospital and Rsearch Centre |
Department of Anaesthesia ,5th Floor,Hi-techDe building ,Dr. D.Y.Patil Medical College,Hospital and Rsearch Centre , Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA |
8884181748
goodheartpragya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and recognition committe under the faculty of medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anesthesia alone |
General anesthesia is given using induction agents in laproscopic gynacological procedures |
| Intervention |
Spinal combined with general anaesthesia |
Combination of spinal anaesthesia given using inj bupivaicaine 2.5ml follwed by general anaesthesia in patients Undergoing laproscopic gynaecological procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients aged between 18 and 60 years 2.american society of anaesthesiologists asa 1 and asa 2.
3.patients posted for laproscopic hysterectomy. |
|
| ExclusionCriteria |
| Details |
• Patients who refused SA
Patients with ASA III or more.
MPC lll and lV patients (anticipated difficult airway).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of combined spinal and general anaesthhesia with only general anaesthesia in patients ungergoing laproscopic gynaecological procedures and to study hemodynamic changes during creation of pneumoperitoneum throughout surgery. |
After giving spinal anaesthesia ,20 mins are waited then general anaesthesia given .we assess the total dose of metoptrolol required ,average concentration of isoflurane required and surgeons satisfaction score and regression of spinal action will be be recorded in postoperative room . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of combined spinal & general anaesthhesia with only general anaesthesia in patients ungergoing laproscopic gynaecological procedures & to study hemodynamic changes during creation of pneumoperitoneum throughout surgery. |
After giving spinal anaesthesia ,20 mins are waited then general anaesthesia given .we assess the total dose of metoptrolol required ,average concentration of isoflurane required & surgeons satisfaction score & regression of spinal action will be be recorded in postoperative room . |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2024 |
| 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
|
it is a prospective ,randomized , comparative study to compare spinal anaesthesia combined with general anaesthesia versus only general anaesthesia in laproscopic gynaecological surgeries.
parameters that will be compared between two groups will be changes in map during creation of pneumoperitoneum ,average inspiratory concentration of isoflurane ,recovery time and surgeons satisfaction score at the end of surgery. |