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Ringer Lactate Preloading on Induction Dose Requirement of Propofol

Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05777135
Enrollment
60
Registered
2023-03-21
Start date
2023-04-01
Completion date
2024-06-30
Last updated
2023-04-05

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

Conditions

Anesthesia, Ringer's Lactate

Brief summary

* 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.

Detailed 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

Interventions

DRUGRinger Lactate prior to surgery and Propofol

Ringer Lactate prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted

Sponsors

National Medical College Birgunj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Propofol dose Required (mg)Standard dosing in OperationPropofol dose (mg) with aspect to weight (kg)
Total Propofol dose given (mg)Visualization of loss of eyelash reflexPropofol dose (mg)
Loss of eyelash reflex (seconds)Propofol given till loss of eyelash reflexVisualization of loss of eyelash reflex (seconds)

Secondary

MeasureTime frameDescription
Heart rate (beats / minute): At intubation (0 minute)At intubation (0 minute)Heart rate (beats / minute) will be measured with pulse oxymeter
Heart rate (beats / minute): Post intubation (1 minute)Post intubation (1 minute)Heart rate (beats / minute) will be measured with pulse oxymeter
Heart rate (beats / minute): Post intubation (3 minute)Post intubation (3 minute)Heart rate (beats / minute) will be measured with pulse oxymeter
Heart rate (beats / minute): Post intubation (5 minute)Post intubation (5 minute)Heart rate (beats / minute) will be measured with pulse oxymeter
Heart rate (beats / minute): Post intubation (10 minute)Post intubation (10 minute)Heart rate (beats / minute) will be measured with pulse oxymeter
Systolic blood pressure (mm Hg): Baseline before IV fluid infusionBaseline before IV fluid infusionSystolic blood pressure (mm Hg) will be recorded on vital monitor
Systolic blood pressure (mm Hg): After IV PropofolImmediately After IV PropofolSystolic blood pressure (mm Hg) will be recorded on vital monitor
Systolic blood pressure (mm Hg): At intubation (0 minute)At intubation (0 minute)Systolic blood pressure (mm Hg) will be recorded on vital monitor
Systolic blood pressure (mm Hg): Post intubation (1 minute)Post intubation (1 minute)Systolic blood pressure (mm Hg) will be recorded on vital monitor
Systolic blood pressure (mm Hg): Post intubation (3 minute)Post intubation (3 minute)Systolic blood pressure (mm Hg) will be recorded on vital monitor
Systolic blood pressure (mm Hg): Post intubation (5 minute)Post intubation (5 minute)Systolic blood pressure (mm Hg) will be recorded on vital monitor
Systolic blood pressure (mm Hg): Post intubation (10 minute)Post intubation (10 minute)Systolic blood pressure (mm Hg) will be recorded on vital monitor
Diastolic blood pressure (mm Hg): Baseline before IV fluid infusionBaseline before IV fluid infusionDiastolic blood pressure (mm Hg) will be recorded on vital monitor
Units of Measure (e.g., weight and height)Preanaesthetic checkup, Day 1Weight in kilograms, height in meters ( weight and height will be combined to report BMI in kg/m²).
Diastolic blood pressure (mm Hg): At intubation (0 minute)At intubation (0 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Diastolic blood pressure (mm Hg): Post intubation (1 minute)Post intubation (1 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Diastolic blood pressure (mm Hg): Post intubation (3 minute)Post intubation (3 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Diastolic blood pressure (mm Hg): Post intubation (5 minute)Post intubation (5 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Diastolic blood pressure (mm Hg): Post intubation (10 minute)Post intubation (10 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): After IV PropofolImmediately After IV PropofolDiastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): Baseline before IV fluid infusionBaseline before IV fluid infusionDiastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): At intubation (0 minute)At intubation (0 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): Post intubation (1 minute)Post intubation (1 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): Post intubation (3 minute)Post intubation (3 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): Post intubation (5 minute)Post intubation (5 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Mean arterial pressure (mm Hg): Post intubation (10 minute)Post intubation (10 minute)Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Diastolic blood pressure (mm Hg): After IV PropofolImmediately After IV PropofolDiastolic blood pressure (mm Hg) will be recorded on vital monitor
Heart rate (beats / minute): After IV PropofolImmediately After IV PropofolHeart rate (beats / minute) will be measured with pulse oxymeter
Heart rate (beats / minute): Baseline before IV fluid infusionBase line Before IV fluid infusionHeart rate (beats / minute) will be measured with pulse oxymeter

Countries

Nepal

Contacts

Primary ContactDr Arushi Jaiswal
arushij.dr16@gmail.com+9779841675096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026