| CTRI Number |
CTRI/2024/05/067921 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing intranasal versus intravenous nitroglycerine to reduce hemodynamic changes that occur during carbon dioxide insufflation in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Efficacy of intranasal versus intravenous nitroglycerine in laparoscopic cholecystectomy - A Randomized controlled trial. |
| 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. Shruti Panda |
| Designation |
Postgraduate Resident |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology, 3rd floor OT complex, Kalinga Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439871835 |
| Fax |
|
| Email |
2387018@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Laba Kumar Nayak |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology, 3rd floor OT complex, Kalinga Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439014811 |
| Fax |
|
| Email |
labakumar.nayak@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ayesha Pattnaik |
| Designation |
Assistant Professor, Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology, 3rd floor OT Complex, Kalinga Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439616053 |
| Fax |
|
| Email |
ayesha.pattnaik@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Panda |
| Address |
Department of Anaesthesiology, 3rd floor OT complex, Kalinga Institute of Medical Sciences, Patia,Bhubaneswar,Odisha,Pincode-751024 |
| 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 Shruti Panda |
Kalinga Institute of Medical Sciences |
Department of Anaesthesiology, 3rd Floor OT Complex, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar, Pincode 751024
Khordha
ORISSA |
9439871835
2387018@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A Intranasal Nitroglycerine |
Group A will receive dose of 400 mcg of intranasal nitroglycerine spray. |
| Intervention |
B Intranasal Nitroglycerine |
Group B will receive dose of 800 mcg of intranasal nitroglycerine spray. |
| Comparator Agent |
C Intravenous Nitroglycerine |
Group C will receive bolus dose of 2 mcg/kg of intravenous nitroglycerine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 60 yrs of either sex.
2.ASA Physical class I and II posted for elective laparoscopic cholecystectomy.
3.Individuals with BMI 19-28 kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Systolic blood pressure less than 90 mm Hg.
2.Allergy to nitrates.
3.Patients who are on Phosphodiesterase Inhibitors, Antihypertensives or sympathomimetics
4.Patients with known nasal pathologies.
|
|
|
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 evaluate the effect on Mean Arterial Pressure. |
T0 – 3 mins before pneumoperitoneum
T1- At the time of pneumoperitoneum
T2 – 2 mins after pneumoperitoneum
T3 – Every 2 mins for first 10 mins
T4- Every 15 mins till end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Effect on SBP,DBP,HR at various time intervals
2)To study the incidence of PONV, headache.
|
-T0 – 3 mins before pneumoperitoneum
-T1- At the time of pneumoperitoneum
-T2 – 2 mins after pneumoperitoneum
-T3 – Every 2 mins for first 10 mins
-T4- Every 15 mins till end of surgery
|
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="2"
Months="0"
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
|
Nitroglycerine is an
organic nitrate which is a venous as well as arterial dilator which releases
nitric oxide and causes relaxation of vascular smooth muscles. Dilation of
larger veins promotes peripheral pooling of blood which in turn reduces
preload. At higher doses, it leads to arterial relaxation which reduces
systemic vascular resistance and hence, the afterload.
There are few studies available in the
literature regarding the use of intranasal nitroglycerine and intravenous
nitroglycerine for attenuation of pressure response. Intranasal
nitroglycerine as an alternative to conventional intravenous route has recently
been shown to have positive perioperative outcomes in multiple studies. The preferable route of nitroglycerine administration
to achieve this without causing much side effects is not yet clear. Hence, this
study is designed to find out preferable route of nitroglycerine administration
for reducing the hypertensive response to pneumoperitoneum. |