| CTRI Number |
CTRI/2024/08/072486 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| 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
|
Impact on intraoperative blood pressure and heart rate during surgery with propofol versus sevoflurane anesthesia. |
|
Scientific Title of Study
|
Propofol Total Intravenous Anaesthesia versus Sevoflurane Inhalational Anaesthesia on Haemodynamic Response Profile during Suspension Laryngoscopy in Adults undergoing Micro laryngeal Surgery.A Randomized 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 Prabhat Kumar Choudhary |
| Designation |
Senior Consultant |
| Affiliation |
Institute of Anaesthesiology, Pain & Perioperative Medicine |
| Address |
Room no 10, 5th floor, SSRB Block, Sir Ganga Ram Hospital, Rajinder Nagar
Central
DELHI
110060
India |
| Phone |
9210770480 |
| Fax |
|
| Email |
drprabhat_sgrh@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anagha Rajeev Karamakkal |
| Designation |
DNB trainee |
| Affiliation |
Institute of Anaesthesiology, Pain & Perioperative Medicine |
| Address |
Room no 10, 5th floor, SSRB Block, Sir Ganga Ram Hospital, Rajinder Nagar
Central
DELHI
110060
India |
| Phone |
9789957623 |
| Fax |
|
| Email |
anagharjv0405@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhat Kumar Choudhary |
| Designation |
Senior Consultant |
| Affiliation |
Institute of Anaesthesiology, Pain & Perioperative Medicine |
| Address |
Room no 10, 5th floor, SSRB Block, Sir Ganga Ram Hospital, Rajinder Nagar
Central
DELHI
110060
India |
| Phone |
9210770480 |
| Fax |
|
| Email |
drprabhat_sgrh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi, 11006 |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital Marg, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi, 11006 |
| 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 Prabhat Kumar Choudhary |
Sir Ganga Ram Hospital |
Ot complex
Institute of anaesthesia, pain and palliative medicine
Fifth floor, ssrb building
Fifth Floor SSRB
Building
Central
DELHI |
9210770480
drprabhat_sgrh@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
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 |
| Intervention |
Propofol |
Patients will receive intravenous propofol for both induction and maintenance of anaesthesia intraoperatively.
After intubation, in the propofol group,
the TCI-pump (Alaris plus PK ,Care Infusion UK Ltd, Hampshire, UK)
programmed to Marsh model will be connected, with the target plasma site
concentration of 3-µg/ml.The infusion rate will be altered to maintain a target
BIS of 50 during maintenance throughout the duration of surgery. |
| Comparator Agent |
Sevoflurane |
Patients will receive intravenous propofol for induction and sevoflurane inhalational for maintenance of anaesthesia intraoperatively.
For patients in the sevoflurane group after
anaesthesia induction, sevoflurane delivery via sevoflurane vaporiser will be started. Sevoflurane MAC will
be adjusted between 0.7-2.0, to maintain BIS value in the range 40-50 throughout the duration of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with laryngeal pathology undergoing microlaryngeal surgery (MLS)
ASA physical status I and II |
|
| ExclusionCriteria |
| Details |
1. ASA GR III AND IV (uncompensated cardiovascular, hepatic, or renal disease)
2. Psychiatric or neurological disorder
3. Uncontrolled endocrine disease (diabetes mellitus, hypothyroidism)
4. Known allergy or hypersensitivity to the study drug.
5. Drug dependence or substance abuse
6. Refusal to informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes during suspension laryngoscopy (heart rate, Systolic blood pressure) |
At pre-induction, post-induction, post endotracheal intubation, every 3 minutes post insertion of rigid laryngoscope till its removal and every 30 minutes (for first 2 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency of adverse haemodynamic effects
Use of rescue drugs for maintaining haemodynamics |
pre induction, post-induction, post endotracheal intubation, every 3 minutes post insertion of rigid laryngoscope till its removal & every 30 minutes (for first 2 hours) |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
07/09/2024 |
| 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="1"
Months="5"
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
|
Micro-laryngeal surgery
(MLS) aided by suspension laryngoscope is a short, microscopic
surgical procedure. It results in a
robust sympathetic response due to stimulation of the
laryngeal tissues resulting in an undue haemodynamic
stress: tachycardia, hypertension and arrhythmias. These haemodynamic responses
though common and benign, rarely may result in fatal complications
in patients with cardio-vascular co-morbidities. Hence, controlling
these haemodynamic perturbations becomes of paramount importance. Of
the various pharmacologic agents and techniques tried to
attenuate the cardiovascular stress response during
MLS under suspension laryngoscopy, two commonly
used general anaesthetics, sevoflurane (an inhalational
agent), and propofol (an intravenous agent) have
found favour. Though both attenuate haemodynamic responses, the efficacy of
neither is so well established. This randomised study proposes
to evaluate propofol total intravenous anaesthesia (TIVA) versus sevoflurane inhalational
anaesthesia on haemodynamic control profile in adult patients undergoing MLS
using suspension laryngoscope.
All
patients undergoing elective MLS will be screened,
and those eligible will be enrolled. Enrolled patients
will receive either propofol TIVA or sevoflurane inhalational anaesthesia.
Demographic and clinical details of the patients will be noted. Haemodynamic
changes (pulse rate and systolic blood pressure) during suspension laryngoscopy
between them will be compared. Other intraoperative outcomes: frequency of
adverse haemodynamic events (hypotension, hypertension, bradycardia,
tachycardia), use of rescue drugs for maintaining haemodynamics (mephentermine,
tri-nitroglycerine, atropine, metoprolol); and postoperative outcomes: postoperative sedation
(assessed using Modified Observer’s Assessment of Alertness/Sedation
scale [MOAA/S]) will be compared. We expect to enrol 42-patients in our
study. |