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Amount of propofol required to produce anaesthesia when given with fentanyl or dexmedetomidine with exclusive intravenous drugs

Phase 4
Completed
Conditions
Medical and Surgical,
Registration Number
CTRI/2022/11/047007
Lead Sponsor
Lady Hardinge Medical College
Brief Summary

**T**otal **i**ntra**v**enous **a**nesthesia(TIVA) is a technique of general anesthesia which uses a combination of agentsgiven via syringe pump exclusively by the intravenous route without theuse of inhalation agents. Propofol-based TIVA techniques offer many advantagesincluding:-lower incidence of post-operative nausea and vomiting, less operatingroom pollution, reduced emergence delirium, quicker recovery, reduced airwayreactivity, laryngospasm and bronchospasm, advocated for neuromuscular disease,core myopathies, muscular dystrophy and reliable delivery using target controlled infusion (TCI)1

ATCI pump contains a microprocessor programmed with pharmacokinetic models forrelevant drugs. The user selects the drug and pharmacokinetic model to be usedby that TCI pump and inputs the patient characteristics (covariates) such asbody weight and age, and the target plasma or ‘brain’ (effect-site)concentration, with the pump determining the initial bolus and subsequentinfusion rates. The two most commonly used adult propofol models areMarsh and Schnider2 which utilize the principle of targetconcentration. The target concentration is the concentration desired in theplasma or at the effect site. The plasma and effect site concentrations are thesame at steady-state. The target concentration will differ depending on themagnitude of the desired effect. A propofol effect site concentration of 2 to 3µg/ml is an appropriate target for sedation, and 4 to 6 µg/ml is adequate foranaesthesia.2 TIVA using TCI can be conducted either with asingle drug or with a combination of drugs. Short acting analgesics have to be administered foranalgesia along with propofol such as ketamine or dexmedetomidine. Thus,the requirement of propofol is likely to decrease because of synergisticeffect.

Different adjuvants when combined with propofol for TIVA have been shown to reduce the effect site concentration of propofol, however, there is limited data on the median effect site concentration of propofol required for anaesthesia along with fentanyl or dexmedetomidine. Therefore, this study is being designed to compare the median effect site concentration of propofol with fentanyl or dexmeditomidine for TIVA.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
80
Inclusion Criteria

ASA I and II.

Exclusion Criteria
  • 1.Laparoscopic surgery with an anaesthetic duration of >3hours.
  • 2.Any known allergy to drugs used in the study.
  • 4.Known psychiatric illness.
  • 5.Addiction to drugs and alcohol.
  • 6.Chronic opioid therapy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean/ Median effect site concentration (EC50) of propofol with fentanyl or dexmeditomidine will be compared by using Student’s t test/ Mann Whitney U test.At the end of anaesthesia
Secondary Outcome Measures
NameTimeMethod
1 Number of patients having side effects2 Mean time to achieve modified aldrete score more than equal to 9

Trial Locations

Locations (1)

Lady Hardinge Medical College

🇮🇳

Delhi, DELHI, India

Lady Hardinge Medical College
🇮🇳Delhi, DELHI, India
Ankita Singh
Principal investigator
9968667500
ankitasingh.2315@gmail.com

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