| CTRI Number |
CTRI/2023/03/050700 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparitive |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF 2% LIGNOCAINE INJECTION ON PROPOFOL CONSUMPTION IN PATIENTS UNDERGOING COLONOSCOPY |
|
Scientific Title of Study
|
Effect of Preservative free 2% Lignocaine Hydrochloride on Propofol consumption in patients undergoing colonoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Freeda Praveena Cutinha |
| Designation |
Postgraduate in M.D Anaesthesiology |
| Affiliation |
Kasturba Medical College & Hospitals, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light house Hill Road, Hampankatta, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8197967512 |
| Fax |
|
| Email |
freeda810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaila S Kamath |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light house Hill Road, Hampankatta, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9844090231 |
| Fax |
|
| Email |
shaila.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaila S Kamath |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light house Hill Road, Hampankatta, Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9844090231 |
| Fax |
|
| Email |
shaila.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Dakshina Kannada, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Freeda Praveena Cutinha |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light house Hill Road, Hampankatta, Mangalore. |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Freeda Praveena Cutinha |
Kasturba Medical College Hospitals. |
Department of Anaesthesiology, Kasturba Medical College, Mangalore,575001
Dakshina Kannada
KARNATAKA |
8197967512
freeda810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged more than 20 years and less than 60 years.
Patients with American Society of Anaesthesiolgists(ASA I and II).
Patients scheduled for colonoscopy.
BMI <30.
Time for the procedure fewer than 45 mins. |
|
| ExclusionCriteria |
| Details |
Age less than 20 years and more than 60 years.
American society of Anaesthesiologists(ASA) III and above.
Procedure time more than 45 minutes.
Pregnancy and Lactation.
Pre-existing hypoxemia( Pulse oximetry SpO2<90%)
Hypotension (Systolic blood pressure <90mmHg)
Bradycardia(Heart rate<50beats/minute)
Uncontrolled Hypertension(Systolic blood pressure >170mmHg, Diastolic blood pressure >100 mmHg)
Respiratory Insufficiency.
Severe Renal or Liver Failure.
Allergy to Lignocaine.
Atrioventricular block.
Neuropsychiatric disorders using sedative hypnotics.
Analgesics >3 months .
Previous colectomy.
Hyperalgesia or Refractory cancer pain.
Intravenous anesthesia contraindication.
Epilepsy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Induction Dose of Propofol for the Procedure.
Maintenance Dose of Propofol for the Procedure.
Total amount of Propofol administered during the procedure.
Induction time.
Recovery time. |
During induction
After induction
1 min
3 mins
5 mins
10 mins
15 mins
20 mins
25 mins
30 mins
35 mins
40 mins
45 mins
At the end of procedure
At the time of recovery
1 hour
2 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intra Operative Hemodynamic Variables.
-Heart Rate (HR).
-Systolic Blood Pressure (SBP).
-Diastolic Blood Pressure (DBP).
-Mean Arterial Pressure (MAP).
-Oxygen Saturation (SpO2).
-Respiratory Rate (RR).
2.Pain Reduction on Injection with Propofol assessed by VAS 1-10.
3.Ease of Procedure for Endoscopist assessed 6-point Likert Scale.
4.Recovery time.
5.Patient Satisfaction and comfort during the procedure assessed by 6-point Likert scale and Modified Gloucester comfort scale respectively.
6.Post Procedure events
-Pain and Fatigue assessed by VAS 1-10.
-Recall.
-Dizziness.
-Nausea and Vomiting.
|
During induction
After induction
1 min
3 mins
5 mins
10 mins
15 mins
20 mins
25 mins
30 mins
35 mins
40 mins
45 mins
At the end of procedure
At the time of recovery
1 hour
2 hour |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- This
study aims at evaluating whether Intravenous 2% Lignocaine Hydrochloride
administration can reduce Propofol dose requirement, and pain reduction on
injection of propofol.
- To
study the effect of 2% Intravenous Lignocaine Hydrochloride with Propofol
in preserving hemodynamic and respiratory normality.
- To compare the ease of
procedure for endoscopists and patient satisfaction and comfort during the
procedure
|