| CTRI Number |
CTRI/2025/11/097597 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Gabapentin, Melatonin, and Clonidine in Reducing Blood Pressure and Heart Rate Changes During Intubation in Treated Hypertensive Patients |
|
Scientific Title of Study
|
A comparative study of effect of pre-treatment with oral Gabapentin versus Melatonin versus Clonidine on hemodynamic response to laryngoscopy and tracheal intubation in controlled hypertensive patients: 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 |
Dr Prathibha R Mudgal |
| Designation |
Post graduate Junior Resident |
| Affiliation |
AIIMS Raipur |
| Address |
B block OT complex, 4th floor, All India Institute of Medical Sciences, Raipur, Great Eastern Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Anaesthesiology Office, B block OT complex, Department of Anaesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur, Great Eastern Road, Opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9886735614 |
| Fax |
|
| Email |
prathibham27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Khobragade |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raipur |
| Address |
B block OT complex, 4th floor, All India Institute of Medical Sciences, Raipur, Great Eastern Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Anaesthesiology Office, B block OT complex, Department of Anaesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur, Great Eastern Road, Opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9820961117 |
| Fax |
|
| Email |
drpradeepk1117@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Khobragade |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raipur |
| Address |
B block OT complex, 4th floor, All India Institute of Medical Sciences, Raipur, Great Eastern Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Anaesthesiology Office, B block OT complex, Department of Anaesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur, Great Eastern Road, Opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9820961117 |
| Fax |
|
| Email |
drpradeepk1117@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
Great Eastern Road, Tatibandh, Raipur, Chhattisgarh- 492099 |
| 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 Prathibha R Mudgal |
AIIMS Raipur |
B block OT complex, Department of Anaesthesiology, B block, 4th floor, All India Institute of Medical Sciences, Raipur, Great Eastern Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
9886735614
prathibham27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur, Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Premedication with Oral Clonidine |
Controlled hypertensive patients on medication posted for elective surgeries under General Anesthesia will receive Tablet Clonidine 100mcg orally one hour prior to induction of anesthesia. |
| Comparator Agent |
Premedication with Oral Gabapentin |
Controlled hypertensive patients on medication posted for elective surgeries under General Anesthesia will receive Tablet Gabapentin 300mg orally one hour prior to induction of anesthesia. |
| Comparator Agent |
Premedication with Oral Melatonin |
Controlled hypertensive patients on medication posted for elective surgeries under General Anesthesia will receive Tablet Melatonin 3mg orally one hour prior to induction of anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 and 60 years
2. Patients giving written informed consent
3. Controlled hypertensive patients on treatment with BP less than 130/80mmHg
4. ASA grade II patients
5. Patients undergoing elective surgery under General anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patients taking Gabapentin, Melatonin or Clonidine
2. Patients having anticipated difficult airway
3. Patients with other coexisting diseases like Diabetes, Ischemic heart disease, Renal or Hepatic disorders, Arrhythmias.
3. Body Mass Index greater than 25 kg/m²
4. Patients on Beta blockers
|
|
|
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 |
| To determine which of the following drugs, Gabapentin, Melatonin or Clonidine will blunt the hemodynamic changes caused during laryngoscopy and intubation better in treated hypertensive patients. |
1. Baseline vitals prior to induction of anesthesia
2. Vitals during laryngoscopy and tracheal intubation
3. Vitals 1,2,3,4,5,10,15 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the Visual Analogue Scale for anxiety (VAS-A) of the patients |
1. VAS-A prior to administration of premedication
2. VAS-A prior to induction of anesthesia |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 2 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prathibham27@gmail.com].
- For how long will this data be available start date provided 30-01-2027 and end date provided 30-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Title of the study: A comparative study of effect of pre-treatment with oral Gabapentin versus Melatonin versus Clonidine on hemodynamic response to laryngoscopy and tracheal intubation in controlled hypertensive patients: A double-blinded, randomized controlled study.
Background: Direct laryngoscopy and endotracheal intubation cause a reflex sympathetic response that leads to increased heart rate, blood pressure, and risk of arrhythmias. This response usually peaks within one to two minutes and settles by five to six minutes, though tachycardia may last up to ten minutes. Hypertensive patients are more vulnerable due to their higher risk of heart and brain vessel diseases. Gabapentin, originally used for epilepsy and neuropathic pain, may reduce this response possibly through calcium channel modulation. Melatonin, a natural hormone with sedative and anxiolytic effects, has also been shown to reduce cardiovascular changes during intubation. Clonidine, a drug for high blood pressure with central sympatholytic effects, can similarly blunt the hemodynamic response when given as premedication.
Justification of the study: Various drugs like calcium channel blockers, beta blockers, and opioids have been used to reduce the hemodynamic response to laryngoscopy and intubation to prevent complications such as myocardial ischemia and cerebral hemorrhage. Recently, clonidine, gabapentin, and melatonin have been studied for this purpose. This study aims to compare their effectiveness in attenuating the pressor response in treated hypertensive patients, a group for which limited data is available.
Objective: This study aims to compare the effectiveness of Gabapentin, Melatonin, and Clonidine in blunting the hemodynamic response to laryngoscopy and intubation in treated hypertensive patients. In addition to evaluating the primary outcome, the study will also assess patients’ anxiety levels prior to induction and monitor for any side effects associated with the use of these study drugs.
Methodology: In this study, eligible patients who provided consent were randomized and allocated into three groups. Each group received pretreatment one hour before induction: Group A was given oral Gabapentin 300 mg, Group B received oral Melatonin 3 mg, and Group C was administered oral Clonidine 100 mcg. Following pretreatment, all patients underwent laryngoscopy and endotracheal intubation. Patients who required multiple intubation attempts or had an intubation time exceeding 30 seconds were excluded from the study. Data from the remaining participants were collected and subjected to statistical analysis.
|