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A study for safe anaesthesia in laparoscopic surgeries

Target controlled infusion with propofol in laparoscopic surgeries-a randomised controlled double-blind study of haemodynamic effects with fixed dose intravenous infusion of fentanyl or dexmedetomidine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045427
Enrollment
62
Registered
2022-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Fixed dose intravenous infusion of dexmedetomidine: Inj. Dexmedetomidine is started with bolus dose 1�mcg/kg and followed by infusion (0.5 mcg/kg/hr) before activation of propofo

Sponsors

Vijaynagar institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American society of Anaesthesiologists physical status 1 to 2 Non obese(BMI 18.5 to 29)

Exclusion criteria

Exclusion criteria: Refusal of patient consent Patients with significant systemic diseases Patients on long term and concurrent sedative intake

Design outcomes

Primary

MeasureTime frame
Stability of haemodynamic parameters during laparoscopy (with changes in mean arterial pressure as primary objective)Timepoint: 1)on arrival to operating room,2)after bolus doses of test drugs,3)pre induction,4)post intubation (1 min, 2min, 5min,10min),5)at initiation of pneumo insufflation, 6)post pneumo- insufflation, 7)every 5�minutes till end of procedure;8)after removal of trocar, 9)stop of propofol infusion , 10)administration of reversal, 11)at extubation, 12)1 min, 2min, 5min and10min following extubation till shift out to Post anesthesia care unit (PACU)

Secondary

MeasureTime frame
correlation of TCI propofol with the state entropy levels i.e the effecctor site concentration value of propofol and corresponding state entropy valuesTimepoint: Effector site concentration of propofol and corresponding state entropy values measured on 1)shifting in ot,2)after bolus doses of test drugs, 3)pre induction, 4)at intubation 5)following intubation at(1 min, 2min, 5min,10min),6) initiation and end of pneumo insufflation, and 7)every 5minutes till end of procedure,8)removal of trocar, 9)stop of propofol infusion, 10)administration of reversal, 11) extubation, 12)1 min, 2min, 5min and10min following extubation ;Postop nausea and vomiting assesment in PACU and postop wards by PONV Impact scale (4 point likert scale) along with vomiting countsTimepoint: IN PACU AND postop wards,every 2nd hourly for 24 hours;total propofol dose usedTimepoint: at the end of surgery

Countries

India

Contacts

Public ContactDr Bala Bhaskar S

Vijaynagar institute of medical sciences

sumithdhulange649@gmail.com8217424749

Outcome results

None listed

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