| CTRI Number |
CTRI/2022/10/046140 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of esmolol v/s dexmedetomidine on blood pressure and heart rate during and after laryngoscopy and endotracheal intubation in patients undergoing elective laprascopic gynecological surgeries. |
|
Scientific Title of Study
|
COMPARISON OF ESMOLOL VERSUS DEXMEDETOMIDINE FOR SUPPRESSION OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC GYNECOLOGICAL SURGERY: A RANDOMIZED INTERVENTIONAL STUDY AT SMS MEDICAL COLLEGE,JAIPUR-DURING 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrChandrashekhar Chatterjee |
| Designation |
Senior professor |
| Affiliation |
Sawai man Singh medical college Jaipur |
| Address |
Department of anesthesiology Sawai man Singh medical college Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChandrashekhar Chatterjee |
| Designation |
Senior professor |
| Affiliation |
Sawai man Singh medical college Jaipur |
| Address |
Department of anesthesiology Sawai man Singh medical college Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmpal Atal |
| Designation |
Junior resident |
| Affiliation |
Sawai man Singh medical college ,Jaipur, Rajasthan, India |
| Address |
Department of anesthesiology Sawai man Singh medical college Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
917620936184 |
| Fax |
|
| Email |
dharmpalatal4@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS medical college and attached hospital |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology Sawai mansingh medical college and attached hospitals |
| Address |
JLN Marg adrash nagar Jaipur |
| Type of Sponsor |
Government 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 |
| Dr chandrasekhar Chatterjee |
SMS medical college |
Department of anaesthesiology Dhanvantri 2nd floor Sawai mansingh medical college and attached hospitals Jaipur
Jaipur
RAJASTHAN |
9828088092
chatterjee.chandrashekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of ethics committee SMS medical college and attached hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (2) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous DEXMEDETOMIDINE |
Intravenous DEXMEDETOMIDINE(1microgram/kg) will be given to determine hemodynamic response from baseline laryngoscopy and intubation |
| Comparator Agent |
Intravenous ESMOLOL |
Intravenous ESMOLOL(1.5mg/kg) will be given to determine hemodynamic response from baseline during laryngoscopy and intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA grade 1-2.
2.patients body weight 40-70 kgs.
3.undergoing laparoscopic gyencological surgery. |
|
| ExclusionCriteria |
| Details |
1.patients not willing to give consent.
2.patients with anticipated difficult airway and laryngoscopy time more than 20 seconds.
3. Chronic disease -hypertension , diabetes,hepatic disease.
4.patients on beta blockers.
5.pregnant and lactating women. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in change in hemodynamic response from baseline after administrating esmolol and dexmedetomidine during laryngoscopy and endotracheal intubation |
At 1 min 3 min 5 min 7 min 10 min and at 20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine proportion of cases who developed the side effects after administrating drug |
1,3,5,7,10,30min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/10/2022 |
| 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="5"
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
|
The purpose of your study is to compare the effects of esmolol and dexmedetomidine on heart rate and blood pressure in response to laryngoscopy and endotracheal intubation and to find out which drug is more effective. |