| CTRI Number |
CTRI/2025/11/097375 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of 3 medicines dexemedetomidine, nitroglycerin and esmolol- used to control blood pressure and improve the visibility of surgical area in patients undergoing sinus surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of nitroglycerin, esmolol and dexemedetomidine on surgical field condition in patients undergoing functional endoscopic sinus surgery with controlled hypotension under general anaesthesia: An open label and randomized 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 Savitar Malhotra |
| Designation |
Senior consultant |
| Affiliation |
Sir Ganga Ram hospital , New Delhi |
| Address |
Institute of Anaesthesiology, Pain and perioperative medicine,
Sir Ganga Ram hospital, New Delhi
Central
DELHI
110060
India |
| Phone |
9958908713 |
| Fax |
|
| Email |
savitarmalhotra@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitar Malhotra |
| Designation |
Senior consultant |
| Affiliation |
Sir Ganga Ram hospital , New Delhi |
| Address |
Institute of Anaesthesiology, Pain and perioperative medicine,
Sir Ganga Ram hospital, New Delhi
DELHI
110060
India |
| Phone |
9958908713 |
| Fax |
|
| Email |
savitarmalhotra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Princy Singla |
| Designation |
Post diploma DNB trainee |
| Affiliation |
Sir Ganga Ram hospital , New Delhi |
| Address |
Institute of Anaesthesiology, Pain and perioperative medicine,
Sir Ganga Ram hospital, New Delhi
Central
DELHI
110060
India |
| Phone |
7338045165 |
| Fax |
|
| Email |
princysingla.92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, rajender place, New Delhi, India
pin code-110008 |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and perioperative medicine,5th floor SSRB block D,
Sir Ganga Ram hospital,old Rajinder nagar, New Delhi(110060) |
| 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 |
| Dr Savitar Malhotra |
Sir Ganga Ram hospital |
OT 15,7th floor, SSRB building, block D, department of Anaesthesiology, pain and peri operative medicine
Central
DELHI |
9958908713
savitarmalhotra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee SGRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H952||Intraoperative hemorrhage and hematoma of ear and mastoid process complicating a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
controlled hypotension using any one of dexemedetomidine, nitroglycerin, esmolol |
In this study we will use controlled hypotension with target mean arterial blood pressure 60-70 mmHg, during intraoperative period starting the infusion of study drugs by giving loading dose (dexemedetomidine 1 mcg/kg/kg over 10 minutes and esmolol 0.5 mg/kg over 1 minute) just before the induction of anaesthesia and giving continous infusions (dexemedetomidine 0.3-0.5 mcg/kg/hour, nitroglycerin 0.5-2 mcg/kg/min and esmolol 0.5-1 mg/kg/min) after the induction of anaesthesia and titrating these to maintain mean arterial blood pressure between 60-70 mmHg to reduce surgical blood loss which is known to improve surgical field condition in patients undergoing functional endoscopic sinus surgery under general anaesthesia. The infusion of study drugs will be stopped 10 minutes prior to the expected end of surgery. |
| Comparator Agent |
dexemedetomidine, nitroglycerin, esmolol |
in this study we will compare the proportion of patients achieving satisfactory surgical field condition using three different hypotensive agents namely dexemedetomidine, nitroglycerin and esmolol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 -60 years
2. Males and females
3. ASA I or II |
|
| ExclusionCriteria |
| Details |
1. Failure to obtain consent
2. Patients with known cardiovascular, renal or hepatic dysfunction
3. Allergic to study drugs
4. Pregnancy or lactation
5. On treatment with beta blockers
6. Anaemia with baseline hemoglobin less than 8g per dl
7. Mean arteial blood pressure less than 70 mmHg at baseline |
|
|
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 compare the proportion of patients achieving satisfactoy surgical field, who are recieving either of dexemedetomidine, nitroglycerin or esmolol for controlled hypotension in functional endoscopic sinus surgery under general anaestesia |
After start of surgery surgical field score will be assessed by surgeon every 15 minutes till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare among 3 groups:
1. Amount of intraoperative blood loss
2. Hemodynamic profile( mean arterial blood pressure, heart rate)
3. Incidence of hypotension, bradycardia, postopererative nausea and vomiting and postoperative sedation
|
intraoperative period and post operative period of one hour |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/11/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Chronic rhinosinusitis and nasal polyposis are commonly detected diseases that affect a large number of people. This is commonly treated surgically with functional endoscopic sinus surgery(FESS). Earlierit was also done under local anaesthesia which has gradually been replaced by general anaesthesia over years as general anaesthesia provides number of advantages over local anaesthesia such as immobile surgical field, adequate analgesia, effective protection of respiratory tract, controlled ventilation and reduced inconvenience and anxiety to the patient. Major disadvantage of FESS under general anaesthesia is the risk of surgical bleeding. Surgical bleeding decreases the visibility of surgical field and can lead to dangerous complications, increased duration and reduced quality of intervention and is therefore known to be a most serious problem associated with FESS. Controlled hypotension can be used as a specific measure to reduce surgical bleeding. It is defined as pharmacologically induced reduction in mean arterial blood pressure (MAP) by 20-30 percent of baseline or maintaining it between 60-70 mmHg reversibly throughout the surgery. This will be an open label, randomized, comparative study among the three drugs namely dexemedetomidine, nitroglycerin, esmolol. We will enroll a total of 120 patients undergoing FESS under general anaesthesia with 40 patients in each group. Participants will be randomly assigned to one of the 3 groups. Group D (dexemedetomidine)- Loading dose of dexemedetomidine 1mcg/kg will be given over 10 minutes followed by a maintainence infusion of 0.3-0.7 mcg/kg/hour Group N (nitroglycerin)- No loading dose, continuous infusion of nitroglycerin will be given at dose 0.5-2 mcg/kg/min Group E (esmolol)- Loading dose of esmolol 1mg/kg to be infused over 1 minute, followed by continuous infusion of 0.5-1 mg/kg/min All the infusions will be titrated to keep MAP between 60-70 mmHg. In this study we aim to compare the patients achieving satisfactory surgical field with use of any of these 3 drugs. In addition we will compare the amount of intraoperative blood loss, hemodynamic parameters and incidence of hypotension, bradycardia and post operative sedation and post operative nausea and vomiting in patients undergoing FESS under general anaesthesia. In this study we hypothesize that owing to different mechanism of action of the 3 hypotensive agents i.e. dexemedetomidine, nitroglycerin and esmolol, after achieving a target MAP of 60-70 mmHg a difference in surgical field condition will be seen. Null hypothesis in this studt would state that there is no significant difference among the 3 hypotensive agents mentioned above, with regards to surgical field condition |