| CTRI Number |
CTRI/2024/08/072528 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of remifentanyl on intubation response in hyper tensive patients. |
|
Scientific Title of Study
|
Comparison of the effect of remifentanil versus dexmedetomidine on stress response to laryngoscopy in hypertensive patients undergoing surgery under general anaesthesia: a prospective, randomised, double-blind 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 |
Dr Annu Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi institute of medical sciences, Patna |
| Address |
Department of anaesthesia, Neuro OT Complex, First floor, Ward
block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014
Patna
BIHAR
800014
India |
| Phone |
7385161632 |
| Fax |
|
| Email |
anucdry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annu Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi institute of medical sciences, Patna |
| Address |
Department of anaesthesia, Neuro OT Complex, First floor, Ward
block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014
BIHAR
800014
India |
| Phone |
7385161632 |
| Fax |
|
| Email |
anucdry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annu Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi institute of medical sciences, Patna |
| Address |
Department of anaesthesia, Neuro OT Complex, First floor, Ward
block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014
BIHAR
800014
India |
| Phone |
7385161632 |
| Fax |
|
| Email |
anucdry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura,Patna- 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Annu Choudhary |
| Address |
Department of anaesthesia, Neuro OT Complex, First floor, Ward
block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Swati Singh |
Department of anaesthesia, Neuro OT Complex, First floor, Ward
block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Annu Choudhary |
Indira Gandhi Institute of Medical Sciences,Patna |
Department of anaesthesia, first floor, ward block, IGIMS , Patna
Patna
Patna
BIHAR |
7385161632
anucdry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Indira Gandhi Institute of Medical Sciences, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj dexmeditomidine |
Patients in Group D will receive IV dexmedetomidine at the rate of 10 μg/kg/hr for 10 mins |
| Intervention |
inj remifentanyl |
patients in Group R will receive IV remifentanil as 1 mcg/kg bolus over 45 sec followed by 0.2 mcg/kg/min. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Primary Hypertension Grade 1 & 2, ASA II, posted for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
• Patient’s refusal to participate
• Uncompensated cardiovascular, pulmonary, neurological, hepato-renal, endocrine disorders
• Allergy to study drugs
• Any substance abuse disorders.
• Viral marker status positive
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in BIS values on laryngoscopy |
immediately after intubation (Ti) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of time to achieve BIS 50 in between two groups
2. Comparison of total propofol consumption for induction in between the two groups
3. Incidence of any adverse effects in two groups
4. Comparison of change in vital parameter ( HR, MAP,SpO2, RR)
|
Baseline
(0min) 1 min 2 min 3 min 4 min 5 min 6 min 7 min 8 min 9 min 10 min
Before induction After induction Before laryngoscopy After intubation (Ti) 5 min 10 mins 30 min 60 min
end of surgery
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/08/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
While numerous studies have explored different doses of dexmedetomidine or remifentanyl, and indicated its effectiveness in attenuating the hemodynamic pressor response, only a limited number of studies have integrated BIS monitoring, an indicator of satisfactory anesthesia , to compare the efficacy of dexmedetomidine with remifentanil. Both these drugs have sedative and analgesic properties of their own which reduces the stress response. Therefore, this study aims to compare the effects of remifentanil and dexmedetomidine on the stress response to laryngoscopy in patients undergoing surgery under general anesthesia, utilizing BIS monitoring to assess the adequacy of anesthesia and associated haemodyanamic fluctuation in hypertensive patients.
|