| CTRI Number |
CTRI/2025/05/086424 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can a Lignocaine infusion Reduce Painkiller Use During Supratentorial Brain Tumour Surgery Under general Anaesthesia? A Study Comparing It with a Placebo |
|
Scientific Title of Study
|
EFFECT OF CONTINUOUS INTRAVENOUS LIGNOCAINE INFUSION VERSUS PLACEBO ON INTRAOPERATIVE FENTANYL CONSUMPTION IN PATIENTS UNDERGOING SUPRATENTORIAL TUMOUR RESECTION UNDER GENERAL ANAESTHESIA |
| 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 Rachna Bhutani |
| Designation |
Senior Consultant |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Institute of anesthesiology, Pain & Perioperative Medicine,5th Floor, Sir Gangaram Hospital, Old Rajinder Nagar, New Delhi-110060
New Delhi
DELHI
110060
India |
| Phone |
9811199484 |
| Fax |
|
| Email |
rachnabhutani13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arindam Dubey |
| Designation |
Post Graduate Trainee |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Institute of anesthesiology, Pain & Perioperative Medicine,5th Floor, Sir Gangaram Hospital, Old Rajinder Nagar, New Delhi-110060
New Delhi
DELHI
110060
India |
| Phone |
7603077644 |
| Fax |
|
| Email |
arindam999dubey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arindam Dubey |
| Designation |
Post Graduate Trainee |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Institute of anesthesiology, Pain & Perioperative Medicine,5th Floor, Sir Gangaram Hospital, Old Rajinder Nagar, New Delhi-110060
New Delhi
DELHI
110060
India |
| Phone |
7603077644 |
| Fax |
|
| Email |
arindam999dubey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of anesthesiology, Pain & Perioperative Medicine,5th Floor, Sir Gangaram Hospital, Old Rajinder Nagar, New Delhi-110060 |
|
|
Primary Sponsor
|
| Name |
Sir Gangaram Hospital |
| Address |
Institute of anesthesiology, Pain & Perioperative Medicine,5th Floor, SGRH, New Delhi-110060 |
| 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 |
| Dr Rachna Bhutani |
Sir Gangaram Hospital |
5th Floor, SSRB Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi-110060.
Central
DELHI |
9811199484
rachnabhutani13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Sir Gangaram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine group (Group L) |
Patients in the Lignocaine group (Group L) will receive an IV bolus of lignocaine preservative-free 1.5 mg/kg just before induction followed by 2mg/kg/hour iv lignocaine infusion after intubation until the closure of the incision. The attending clinician will give fentanyl during the intraoperative time (during skull pin insertion T1, during incision T2, and during any time in the intraoperative period) if there is tachycardia i.e. increase in heart rate (HR) 20% above baseline for 1 minute and there is hypertension i.e. increase in mean arterial pressure (MAP) 20% above baseline for 1 minute it will be treated by giving injection fentanyl citrate in the bolus of 0.5 mcg/kg after ruling out other potential causes (haemorrhage, arrhythmia, Cushing’s triad-hypertension, bradycardia, irregular respiration). |
| Comparator Agent |
Placebo group (Group S) |
Patients in the Placebo group (Group S) will receive an IV bolus of lignocaine preservative-free 1.5 mg/kg just before induction followed by the same amount, volume, and rate of 0.9% normal saline as a placebo. The attending clinician will give fentanyl during the intraoperative time (during skull pin insertion T1, during incision T2, and during any time in the intraoperative period) if there is tachycardia i.e. increase in heart rate (HR) 20% above baseline for 1 minute and there is hypertension i.e. increase in mean arterial pressure (MAP) 20% above baseline for 1 minute it will be treated by giving injection fentanyl citrate in the bolus of 0.5 mcg/kg after ruling out other potential causes (haemorrhage, arrhythmia, Cushing’s triad-hypertension, bradycardia, irregular respiration). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I and II
Body Mass Index = 18.5-35 kg/m2
Glasgow Coma Score 15
|
|
| ExclusionCriteria |
| Details |
Refusal to give consent for participation
History of allergy to medications to be used in the study
Patient routinely taking opioids within last 2 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare cumulative intraoperative fentanyl consumption in patients undergoing supratentorial tumor resection surgery under general anesthesia, with either intravenous lignocaine infusion or placebo. |
To compare cumulative intraoperative fentanyl consumption in patients undergoing supratentorial tumor resection surgery under general anesthesia, with either intravenous lignocaine infusion or placebo during skull pin insertion T1, during incision T2, and during any time in the intraoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the incidence of fentanyl-related side effects, including postoperative nausea, and vomiting (PONV) during the first 24 hours postoperatively between the two study groups.
2.To compare the rescue analgesic requirements during the first 24 hours postoperatively between the two groups, evaluating the effect of intravenous lignocaine infusion on analgesic consumption.
|
immediately after extubation, one-hour post-extubation in the Post-Anaesthesia Care Unit (PACU), and subsequently at 6 hours, 12 hours, 18 hours, and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/05/2025 |
| 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="9"
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
|
In this double-blind randomized controlled trial, we will enroll
approximately 15 adult
patients in each group scheduled for elective supratentorial tumour surgery.
Participants will
be randomly assigned to two groups: one receiving intravenous lignocaine
infusion
(maintenance infusion of 2 mg/kg/hour) and the other receiving a placebo
(normal saline
infusion). The primary outcome will measure cumulative intraoperative fentanyl
consumption, while secondary outcomes will assess postoperative opioid-related
side effects
and postoperative rescue analgesia requirements. The hypothesis is that intravenous lignocaine infusion will result in lower
cumulative intraoperative fentanyl use, fewer fentanyl-related side effects, and
reduced requirements for analgesia during the perioperative period. The primary objective of the
study is to compare cumulative intraoperative fentanyl consumption in patients undergoing
supratentorial tumour surgery under general anaesthesia with intravenous lignocaine infusion
versus placebo. The secondary objectives are to compare opioid-related side effects and the need
for rescue
analgesia during the postoperative period between the two groups. |