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Comparing intranasal versus intravenous nitroglycerine to reduce hemodynamic changes that occur during carbon dioxide insufflation in laparoscopic cholecystectomy

Efficacy of intranasal versus intravenous nitroglycerine in laparoscopic cholecystectomy - A Randomized controlled trial. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067921
Enrollment
111
Registered
2024-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis Health Condition 2: K808- Other cholelithiasis

Interventions

Intervention1: B Intranasal Nitroglycerine: Group B will receive dose of 800 mcg of intranasal nitroglycerine spray. Control Intervention1: A Intranasal Nitroglycerine: Group A will receive dose of 40

Sponsors

Dr Shruti Panda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect on Mean Arterial Pressure.Timepoint: 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

MeasureTime frame
1)Effect on SBP,DBP,HR at various time intervals 2)To study the incidence of PONV, headache. Timepoint: -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

Countries

India

Contacts

Public ContactDr. Ayesha Pattnaik

Kalinga Institute of Medical Sciences, Bhubaneswar

labakumar.nayak@kims.ac.in9439014811

Outcome results

None listed

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