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Comparing hemodynamic responses for Endotracheal Intubation and Laparoscopic gas inflation with dexmedetomidine and melatonin

Attenuation of haemodynamic effects to intubation and pneumoperitoneum in patients receiving two different doses of dexmedetomidine with addition of melatonin to the lower dosage group during laparoscopic cholecystectomy A prospective randomized double blind trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069624
Enrollment
76
Registered
2024-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Melatonin and Dexmedetomidine: Tablet Melatonin 6mg per oral given 2 hours before shifting the patient to Operation Theatre . Injection Dexmedetomidine at the dose of 0.2 micrograms per

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of ASA class 1 AND 2 undergoing elective laparoscopic cholecystectomy

Exclusion criteria

Exclusion criteria: Patients refusal to give consent Pregnant and lactating women Patients who are allergic to the study drug Patients with uncontrolled cardio, respiratory, renal, hepatic or endocrine disease Conversion of laparoscopic to open cholecystectomy Patients with drains placed insitu Patients who are unable to perform NRS Numerical Rating Scale Surgical time exceeding 150 minutes Baseline heart rate LESS THAN 60 beats PER minute

Design outcomes

Primary

MeasureTime frame
To study the cardiovascular response at different time intervals following creation of pneumoperitoneum in patients of both the groupsTimepoint: At 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes Post creation of pneumoperitoneum—

Secondary

MeasureTime frame
Number of doses of atropine, ephedrine & phenylephrine required intraoperatively between the two groupsTimepoint: Intraoperatively;Number of propofol boluses required perioperativelyTimepoint: Intraoperatively;To assess & compare the time for first request of analgesia post operatively defined as whenever the patient complains of pain or when Numerical Rating Scale more than 4, whichever is earlierTimepoint: Post operatively;To compare the post operative sedation score using Observers Assessment of Alertness & Sedation Score between the two groupsTimepoint: at 5,15,30 minutes, 1 hour & 2 hours post extubation;To study the cardiovascular response during intubation Timepoint: 1,3,5 minutes post intubation;To study the induction dose of propofol between the two groupsTimepoint: At the time of induction—

Countries

India

Contacts

Public ContactDr. N. Hemanth

Sri Venkateswara Insitute of Medical Sciences

hemanthn1973@gmail.com9440285634

Outcome results

None listed

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