| CTRI Number |
CTRI/2024/01/061334 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effect of two drugs dexmedetomidine and lignocaine on decreasing cough response after anaesthesia in patients undergoing surgery for brain tumors. |
|
Scientific Title of Study
|
Comparison of Intratracheal Dexmedetomidine versus Lignocaine on Attenuating Emergence Cough Response to Extubation in Patients Undergoing Craniotomy for Intracranial Tumour: A Multi-Arm Randomized Controlled Trial |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shipra Verma |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anaesthsia, UPUMS Saifai
Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9458657706 |
| Fax |
|
| Email |
lamhe.17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shipra Verma |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anaesthsia, UPUMS Saifai
Department of Anaesthsia, UPUMS Saifai
UTTAR PRADESH
206130
India |
| Phone |
9458657706 |
| Fax |
|
| Email |
lamhe.17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra Verma |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai,Etawah |
| Address |
Department of Anaesthsia, UPUMS Saifai
Department of Anaesthsia, UPUMS Saifai
UTTAR PRADESH
206130
India |
| Phone |
9458657706 |
| Fax |
|
| Email |
lamhe.17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Uttar pradesh university of medical sciences |
| Address |
UPUMS, Saifai Etawah
INDIA |
| 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 |
| Shipra Verma |
Uttar pradesh university of medical sciences, SAIFAI |
Department of Anaesthsia, UPUMS Saifai
Etawah
UTTAR PRADESH |
9458657706
lamhe.17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee UPUMS Saifai |
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 |
Control Group |
ï‚·5 ml of 0.9% normal saline will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation |
| Intervention |
Dexmedetomidine Group |
ï‚·Injection Dexmedetomidine (0.5 mcg/kg) diluted with 0.9% normal saline to make a volume of 5 ml will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation. |
| Intervention |
Lignocaine Group |
ï‚·2 % lignocaine 1.5 mg/kg diluted with 0.9% normal saline to make a volume of 5 ml will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I or II class, BMI less than 30,
Undergoing elective craniotomy for intracranial tumor under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patient Refusal
2. Renal impairment
3. Cardiorespiratory abnormalities
4.Bronchial asthma COPD
5. Restrictive lung diseases
6. Liver failure
7. Allergy to drugs will be used
8. Pregnancy-lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the effect of intratracheal dexmedetomidine and intratracheal lignocaine on the emergence cough response by using the emergence cough score |
5 min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters Heart rate,Mean blood pressure, and Oxygen saturation |
Baseline (T0)
15 min before extubation (at the time of intervention drug given) (T1)
10 min before extubation (T2)
5 min before extubation (T3)
At the time of extubation (T4)
5 min after extubation
(T5)
10 min after extubation
(T6)
30 min after extubation
(T7) |
| VAS score |
1 hr after extubation,
2 hrs after extubation, and
12 hrs after extubation |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| Date of Study Completion (India) |
01/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 randomized, double-blind, control study will be conducted on 45 patients after the institutional ethical committee approves.
The study will be carried out at our institute for over 12 months. Randomization will be done using a computer-generated random number table to get an equal number of patients in each group. Both patients and the anaesthesiologist assigned for data collection will be kept blind throughout the study. Different anaesthesiologists will be assigned to study and control drugs. All patients will be randomly allocated into 3 groups of 15 each. · Group DX: Injection Dexmedetomidine (0.5 mcg/kg) diluted with 0.9% normal saline to make a volume of 5 ml will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation. · Group LG: 2 % lignocaine 1.5 mg/kg diluted with 0.9% normal saline to make a volume of 5 ml will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation · Group CN: 5 ml of 0.9% normal saline will be instilled intratracheally into the endotracheal tube 15-20 min before the expected extubation. Emergence cough response, Hemodynamic parameters and Vas score will be assessed. |