| CTRI Number |
CTRI/2024/04/066136 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of drug on extubation response given through nebulization preoperatively |
|
Scientific Title of Study
|
Effect of pre-operative 0.5% Ropivacaine nebulization on extubation response in patients undergoing general anaesthesia - A Double blinded randomized controlled study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAHALAKSHMI |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Pondicherry Institute of Medical Sciences campus,kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7904808339 |
| Fax |
|
| Email |
mahasiva1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMYAVEL |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Pondicherry Institute of Medical Sciences campus, kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAHALAKSHMI |
| Designation |
Post graduate Junior resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Pondicherry Institute of Medical Sciences campus, kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7904808339 |
| Fax |
|
| Email |
mahasiva1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences campus,Ganapathichettikulam, kalapet, Puducherry - 605014 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| MAHALAKSHMI |
Pondicherry Institute of Medical Sciences |
Department of Anaesthesiology Kalapet
605014
Pondicherry
PONDICHERRY |
7904808339
mahasiva1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE 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 |
| Intervention |
0.5% Ropivacaine |
Patient will be administered 5ml of 0.5% Ropivacaine nebulization 5 to 10 minutes before induction of general anaesthesia. |
| Comparator Agent |
normal saline |
Patient will be administered 5ml of 0.9% normal saline 5 to 10 minutes before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age groups 18 to 65 years and belonging to American society of Anesthesiologist physical status classification ASA-PS-I &II.
2. Patient scheduled for elective general anaesthesia procedures.
|
|
| ExclusionCriteria |
| Details |
allergic to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence and severity of cough between preoperative 0.5% Ropivacaine nebulization versus 0.9% normal saline nebulization in patients undergoing general anaesthesia with endotracheal intubation. |
Heart rate, Mean arterial pressure, spo2 will be recorded at baseline, upon tracheal intubation, every 1 minute till 5 minutes, Every 5 minutes after intubation till 20 mins, upon anaesthetic withdrawal, upon eye opening on verbal commands, upon tracheal extubation, immediately after extubation, every 5 minutes after extubation till 20 minutes.
Incidence and severity of cough by Modified 4 point Minogue scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare perioperative hemodynamics, time to extubation, incidence and severity of sore throat |
Hemodynamics will be recorded at baseline,upon tracheal intubation,every 1 minute till 5 minutes,Every 5 minutes after intubation till 20 mins, upon anaesthetic withdrawal,upon eye opening on verbal commands, upon tracheal extubation every 5 minutes after extubation till 20 minutes.
Sore throat recorded at 0,2,4,6 and 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/05/2024 |
| 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="11"
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
|
This is a prospective randomised controlled trial to be con ducted on patients aged 18-60 years belonging to ASA I and II posted for elective surgeries under general anaesthesia. After obtaining Institute’s Ethics Committee clearance and informed written consent, the patients will be randomly allocated to one of the three study groups. All the patients will be kept fasting overnight and will be premedicated with oral lorazepam 1mg on the day before the surgery, oral pantoprazole 40mg and oral metochlopromide 10mg will be given on the day before and also on the morning of surgery. Patients will be shifted to the pre operative holding area 30 minutes before the scheduled surgery and baseline vital parameters will be checked. An 18G IV cannula will be secured over the non operative side hand and maintenance IV fluids will be started at a rate of 10ml/kg/hr. After opening the envelope the drug will be prepared as a uniform 5ml solution, the anaesthesiologist who is not a part of the study. The primary anaesthesiologist blinded to the assignments will administer nebulisation to patients in all groups and will be recording all the study parameters. Drug will be administered as aerosol through nebulisation. Nebulisation will be done with a nebulizer by an insufflation gas (100% oxygen at a flow rate of 10 l/min from a wall mount oxygen port through a 200cm tubing connected from the oxygen port to the face mask attached with a nebuliser. Patient will be propped up and advised to take normal tidal volume breaths. Nebulisation will be continue until the complete solution in the nebulizer got areosolized(10-15 min). Ten minutes after completion of nebulisation, patients will be preoxygenated with 100% oxygen for 5 min and then induced with injection midazolam 30 mcg/kg, fentanyl 2 ug/kg, propofol 2mg/kg, and vecuronium 0.1mg/kg. After 3 min of assisted ventilation, patients will be intubated with the appropriate size endotracheal tube. Anaesthesia will be maintained with O2;N2O; mixture in the ratio of 1:1 and isoflurane at 0.8 to 1 MAC.. Tidal volume was controlled at 7ml/kg, the respiratory rate will be set at 12/min, and the inspiratory/expiratory ratio will be set at 1:2, the cuff pressure will be maintained at 20cm of H2O by hand held cuff pressure manometer. Supplementary analgesia will be provided by injection paracetamol at a dose of 15mg/kg. At the end of the case, orophranyx suctioned, inhalational agent will be stopped and patient will be administered 100% oxygen.After return of spontaneous respiration, neuromuscular blockade will be reversed with of 0.05 mg/kg neostigmine and 0.01 mg/kg of injection glycopyrolate. Trachea will be extubated when patient demonstrated the ability to follow verbal commands or showed purposeful movements in addition to resumption of regular spontaneous respiration. |