| CTRI Number |
CTRI/2024/10/074615 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study about recovery from being completely unconscious and only losing sensation at operative area in patients undergoing abdominal surgeries through minimal cut |
|
Scientific Title of Study
|
Comparison of Quality of Recovery between General Anaesthesia and Thoracic Spinal Anaesthesia in patients undergoing laparoscopic abdominal surgery: A single blinded randomised controlled trial |
| 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 Abhisek Dey |
| Designation |
Junior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8420818459 |
| Fax |
|
| Email |
doclazarus98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS Rishikesh, Level 6, Virbhadra Road, Rishikesh, District: Dehradun, Pincode:249203, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Abhisek Dey |
AIIMS Rishikesh |
Major OT complex, OR 11, Level 6, Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL |
8420818459
doclazarus98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anaesthesia |
Patients will receive General Anaesthesia with IV induction agents
(Propofol/Etomidate/Ketamine), Fentanyl, Midazolam, IV muscle relaxants, then they will be attached to ventilator with maintenance inhalational anaesthesia using Sevoflurane throughout the surgery. All intraoperative vitals, ventilator settings, intake output charting and total amount of drugs used will be noted |
| Intervention |
Thoracic Spinal Anaesthesia |
Patients will receive Thoracic Spinal Anaesthesia in the form of intrathecal catheter with Ketamine, preservative free Midazolam and isobaric Levobupivacaine 0.5% with maintenance sedation by IV Dexmedetomidine resulting in segmental spinal anaesthesia desired at (T4-L1) level. Additionally intraoperative vitals, intake-output charting, total amounts of drugs used for anaesthesia and analgesia will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) grade I-III patients undergoing elective laparoscopic/robotic abdominal surgeries |
|
| ExclusionCriteria |
| Details |
Patients with informed refusal
Patients undergoing emergency and open abdominal surgeries
Patients with severe medical illnesses (ASA IV-V grade)
Patients with known allergy to anaesthestic drugs
Patients having absolute/relative contraindications to spinal anaesthesia
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Recovery following surgery |
At 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the Post Anaesthesia Cre Unit (PACU) stay by using modified Aldrete score |
At every 15 minutes intervals after surgery gets over till patients get discharged from PACU |
| Compare the Length of Stay (LoS) in the hospital |
From the date of Admission (DoA) to Date of Discharge (DoD) |
| To look for any in house new onset morbidity |
Upto 3 months following surgery |
| To compare how satisfied surgeons are |
Baseline at the end of surgery |
| To compare how satisfied patients are |
24 hours of postsurgical timeline |
| To note the percentage conversion to General Anaesthesia |
Baseline at the end of surgery |
| Assessment of in house mortality following surgery |
At 30 and 90 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="6"
Days="10" |
|
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
|
This trial is a randomised single blinded prospective parallel arm active controlled trial to compare Quality of Recovery at 24 hours following surgery as primary outcome with any new onset in house morbidity, mortality, patient’s and surgeon’s satisfaction analyses, percentage conversion to general anaesthesia and ICU stay as secondary outcomes between General Anaesthesia and Thoracic Spinal Anaesthesia group of patients undergoing laparoscopic/robotic elective abdominal surgeries in AIIMS, Rishikesh in approximately next 18 months from the expected date of first allotment |