| CTRI Number |
CTRI/2020/03/023733 [Registered on: 03/03/2020] Trial Registered Prospectively |
| Last Modified On: |
29/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Injected anaesthetic versus inhalational anaesthetic for laparoscopic nephrectomy |
|
Scientific Title of Study
|
Total intravenous anaesthesia vs. Inhalational anaesthesia on quality of recovery in patients undergoing laparoscopic nephrectomy – A randomised controlled trial |
| Trial Acronym |
TINAR Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIJAYALAKSHMIR |
| Designation |
PG REGISTRAR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE VELLORE |
| Address |
DEPARTMENT OF ANAESTHESIA
CHRISTIAN MEDICAL COLLEGE
VELLORE
CHRISTIAN MEDICAL COLLEGE
IDA SCUDDER ROAD
VELLORE 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
8903514505 |
| Fax |
|
| Email |
aarvee93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIJAYALAKSHMIR |
| Designation |
PG REGISTRAR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE, VELLORE |
| Address |
DEPARTMENT OF ANAESTHESIA
CHRISTIAN MEDICAL COLLEGE
VELLORE
CHRISTIAN MEDICAL COLLEGE
IDA SCUDDER ROAD
VELLORE 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
8903514505 |
| Fax |
|
| Email |
aarvee93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KAREN LIONEL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE, VELLORE |
| Address |
DEPARTMENT OF ANAESTHESIA
CHRISTIAN MEDICAL COLLEGE
VELLORE
CHRISTIAN MEDICAL COLLEGE
IDA SCUDDER ROAD
VELLORE 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9442631528 |
| Fax |
|
| Email |
kanjacob@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHRISTIAN MEDICAL COLLEGE VELLORE |
|
|
Primary Sponsor
|
| Name |
CHRISTIAN MEDICAL COLLEGE |
| Address |
CHRISTIAN MEDICAL COLLEGE
IDA SCUDDER ROAD
VELLORE-632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| VijayalakshmiR |
Christian medical College |
Department of Anaesthesia
Christian Medical College
Ida scudder road
Vellore
Vellore
TAMIL NADU |
8903514505
aarvee93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Silver, Office of Research,Carman Block,Christian medical college,Vellore,Tamilnadu. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Propofol |
Infusion of Inj Propofol at a dose of 150 to 200mcg/Kg/minute titrated to a Bispectral Index (BIS) between 40 to 60 |
| Comparator Agent |
Sevoflurane |
Sevoflurane Inhalational Anaesthesia titrated to a Bispectral index (BIS) between 40 to 60 and Minimum Alveolar Concentration between 0.8 and 1.0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective laparoscopic nephrectomy
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
ASA 3 or more
Allergic to local anaesthetics
Serum creatinine >1.4mg/dl
Psychiatric disorders
Chronic opioid usage
Steroid treatment
Patient refusal
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the recovery profile measured by quality of recovery score 15(QoR-15), in patients receiving TIVA using propofol or Inhalational anaesthesia using sevoflurane for laparoscopic nephrectomy at 24 hours after surgery |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the intra-operative hemodynamic profile. |
Intraoperative every 15 minutes from induction to extubation |
| To compare time taken to awaken from anaesthesia |
Time of cessation of anaesthetic to time of obeying commands |
| Intraoperative analgesic requirement |
Cumulattive analgesic use calculated at end of anaesthesia |
To compare intraoperative vasopressor/ inotrope support requirement between two groups
|
Total cumulative dose required from induction to extubation |
| To compare time taken to attain fitness for discharge from PACU |
Assessed every 10 minutes from extubation till Aldrette score greater than 8 |
| To compare the incidence of postoperative nausea and vomiting (PONV) |
Number of episodes during the first 24 hours post operation |
| To compare the recovery profile, measured by quality of recovery score 15 at 48-hours post operation |
48 hours post operation |
| To compare the total dose of morphine consumption at 24hours and 48 hours |
24 and 48 hours postoperative |
| To compare the time to DRink (Time from extubation to the time at which the patient asks for oral fluids), time to EAt solids orally (Time from extubation to the time at which the patient asks for solid food) and the time to Mobilize with support (Time from extubation to the time at which the patient walks with support) (DREAM TIME) |
Time from extubation to completion of each task on demand. |
| To compare the patient satisfaction |
Postoperative 24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2020 |
| Date of Study Completion (India) |
27/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Conventionally, inhalational agents are used for maintenance of anaesthesia in laparoscopic surgeries. These patients always present with multiple co-morbidities. Maintenance of anaesthesia with inhalational agent (0.9 to 1 MAC) causes haemodynamic compromise especially in diabetic and hypertensives. As anaesthesia time progresses (> 3 hours) when we use inhalational agents, the recovery time from anaesthesia also prolonging thereby delaying extubation time and the discharge time from PACU. The postoperative nausea and vomiting (PONV)is higher in laparoscopic surgeries which is not attenuated by inhalational agent. We are hypothesizing that the total intravenous anaesthesia (TIVA) attenuate stress response better compared to inhalational agents, because of its anti-inflammatory and anti-oxidant properties. High concentration of propofol (within the therapeutic range) decreases the CVP without decreasing the cardiac output, ensures the haemodynamic stability. TIVA decreases the incidence of post-operative nausea and vomiting, decreases the tumour recurrence because of its anti-tumour effect on immune cells. All the above mentioned effects will help the patients to recover better following anaesthesia thereby improves the post-operative recovery profile. In this randomized, active comparator study we will compare the recovery profile of those receiving total intravenous anaesthesia with those receiving sevoflurane for maintenance of anaesthesia while undergoing laparoscopic nephrectomy.One-hundred and twenty, ASA 1 and 2 patients aged between 18 and 65 years, undergoing elective laparoscopic nephrectomy will be assigned to either TIVA with propofol (Group A) or inhalational with sevoflurane group (Group B) in a 1:1 randomization using variable block sizes of 4, 6 or 8. While the TIVA group (Group A) will receive only propofol for both induction and maintenance, the sevoflurane group (Group B) will undergo induction with propofol and maintenance with sevoflurane. Participants will be anaesthetized by one of three anaesthesiologists who are the coinvestigators who will follow a standardized protocol. We will titrate the anaesthetic to target a Bispectral (BIS) index of 40-60. Total duration of anaesthesia, surgery, Total dose of opioid and propofol used during surgery will be documented. The recovery from anaesthesia will be assessed by recovery room nurses who will remain blinded to the study assignment. The primary intention to treat analysis will include all randomised patients who have a valid primary endpoint assessment for quality of recovery which will be assessed at 24 hours after surgery (24-26 hours) using a Quality of Recovery-15 (QoR-15) questionnaire by the primary investigator who is blinded about the study intervention. The time to recovery from anaesthesia will be assessed from cessation of anaesthetic to opening eyes to call. Fitness to discharge will be assessed using the modified Aldrette score every ten minutes till the score >=9. No patient will be excluded from the study. Primary outcome QoR 15 is measured at 24 hours after surgery and if this measurement is not possible because the patient is ventilated postoperatively, we cannot make this assessment. The primary analysis for efficacy will be a modified intention to treat analysis that includes all patients in whom the primary endpoint can be assessed. The secondary endpoints will continue to be assessed for all participants. A secondary per-protocol analysis will exclude, in addition, those whose surgery was converted to laparotomy. |