Skip to content

Comparing nasal spray and injection forms of nitroglycerine to control blood pressure changes during laparoscopic surgery.

Comparison of effectiveness of intranasal Nitroglycerine spray versus intravenous bolus Nitroglycerine for attenuation of hemodynamic Response to pneumoperitoneum in laparoscopic Surgery- a double blinded randomized clinical comparative trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089369
Enrollment
72
Registered
2025-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Nitroglycerine Spray: patients will receive intranasal nitroglycerine 400 mcg spray once 2 mins prior to pneumoperitoneum. Blood pressure, peripheral capillary oxygen saturation and hea

Sponsors

IMS and SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults aged between 18-65 years 2.Patients posted for elective laparoscopic 3.American society of anaesthesiologists (ASA) physical status I or II 4.Body Mass Index 18.5-30 kg/m2 5.Non pregnant, Non lactating females 6.Patients who provided written informed consent

Exclusion criteria

Exclusion criteria: Hypersensitivity to nitroglycerine Severe Anaemia History of significant cardiovascular disorders -ischemic heart disease, uncontrolled hypertension, arrhythmias, heart failure Patients on medications which interact with nitroglycerine - sildenafil, nitrates Unable or unwilling to comply with study protocol Patients with ASA greater than 2

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of intranasal nitroglycerine spray versus intravenous nitroglycerine in attenuating the hemodynamic response (changes in blood pressure and heart rate) to pneumoperitoneum during laparoscopic surgery.Timepoint: Blood pressure, peripheral capillary oxygen saturation and heart rate measured at 2 mins before and 2, 4, 6, 8, 10, 15, 30, 45 minutes, and 1 hour after pneumoperitoneum initiation.

Secondary

MeasureTime frame
To see for adverse effects associated with intranasal nitroglycerine & intravenous nitroglycerineTimepoint: Blood pressure, peripheral capillary oxygen saturation & heart rate measured at 2 mins before & 2, 4, 6, 8, 10, 15, 30, 45 minutes, & 1 hour after pneumoperitoneum initiation.

Countries

India

Contacts

Public ContactSushree Das

IMS and SUM Hospital

das.sushri@gmail.com9132425105

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026