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Ringer Lactate Preloading on Induction Dose Requirement of Propofol

N

National Medical College Birgunj

Status and phase

Enrolling
Phase 4

Conditions

Ringer's Lactate
Anesthesia

Treatments

Drug: Ringer Lactate prior to surgery and Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT05777135
519 - 2022

Details and patient eligibility

About

  • To compare the effect (heart rate and mean arterial pressure) of Ringer Lactate preloading and without preloading on induction dose requirement of Propofol.
  • The Propofol requirement for induction dose with respect to loss of eyelash reflex in Ringer Lactate preloaded versus control group.

Full description

  1. From the operation list, patients that meet the Inclusion criteria will be selected. (n=60)

  2. Patients will be allocated into two participant groups. Group I and Group II respectively using Simple random sampling technique by Ballot method. Ballot method is to keep the list of patients that meet the inclusion criteria in two ballot box mentioning name and groups and do the lottery based selection for both groups and Patient code will be given.

  3. Group I (n = 30) Preloading with Ringer Lactate 30 ml/kg over 30 mins prior to surgery will be done and Propofol dose (2mg / kg ) requirement for induction of anaesthesia will be noted.

    Group II (n = 30) No Preloading will be done and Propofol dose (2mg / kg) requirement for induction of anaesthesia will be noted.

  4. Then, investigators will visualize for loss of eyelash reflex in both groups.

  5. The hemodynamic response (heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) to intubation between the two participant groups will be noted. The total Propofol requirement for induction in Ringer Lactate preloaded versus control group will be recorded.

  6. Drug administration and parameters recording will be done by the anaesthesiologist / under supervision

Enrollment

60 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Patients scheduled for elective surgeries
  2. American Society of Anaesthesiologists (ASA) class I patients
  3. Age between 18-45 years
  4. Any surgery under general anaesthesia requiring endotracheal intubation
  5. Body mass index (BMI) -18.5 - 24.9
  6. Those providing written consent

Exclusion criteria

  1. Emergency surgery
  2. Patients with multiple injuries, pregnancy
  3. Airway Mallampati grade II, III and IV
  4. Allergy to Ringer Lactate and Propofol.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Group I (Preloading with Ringer Lactate)
Experimental group
Description:
Preloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted
Treatment:
Drug: Ringer Lactate prior to surgery and Propofol
Group II (No preloading)
No Intervention group
Description:
No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted

Trial contacts and locations

1

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Central trial contact

Dr Arushi Jaiswal

Data sourced from clinicaltrials.gov

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