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

• 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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Ringer's Lactate
• Intervention / Treatment: Drug: Ringer Lactate prior to surgery and Propofol

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr Arushi Jaiswal; Phone Number: +9779841675096; Email: arushij.dr16@gmail.com

Study Locations

• Nepal
  • Province - 2
    • Birgunj, Province - 2, Nepal, 44300
      • Recruiting
      • National Medical College Teaching Hospital
      • Contact: Dr Arushi Jaiswal; Phone Number: +9779841675096; Email: arushij.dr16@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol dose Required (mg)	Propofol dose (mg) with aspect to weight (kg)	Standard dosing in Operation
Total Propofol dose given (mg)	Propofol dose (mg)	Visualization of loss of eyelash reflex
Loss of eyelash reflex (seconds)	Visualization of loss of eyelash reflex (seconds)	Propofol given till loss of eyelash reflex

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate (beats / minute): Baseline before IV fluid infusion	Heart rate (beats / minute) will be measured with pulse oxymeter	Base line Before IV fluid infusion
Heart rate (beats / minute): After IV Propofol	Heart rate (beats / minute) will be measured with pulse oxymeter	Immediately After IV Propofol
Heart rate (beats / minute): At intubation (0 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	At intubation (0 minute)
Heart rate (beats / minute): Post intubation (1 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (1 minute)
Heart rate (beats / minute): Post intubation (3 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (3 minute)
Heart rate (beats / minute): Post intubation (5 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (5 minute)
Heart rate (beats / minute): Post intubation (10 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (10 minute)
Systolic blood pressure (mm Hg): Baseline before IV fluid infusion	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Baseline before IV fluid infusion
Systolic blood pressure (mm Hg): After IV Propofol	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Immediately After IV Propofol
Systolic blood pressure (mm Hg): At intubation (0 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	At intubation (0 minute)
Systolic blood pressure (mm Hg): Post intubation (1 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (1 minute)
Systolic blood pressure (mm Hg): Post intubation (3 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (3 minute)
Systolic blood pressure (mm Hg): Post intubation (5 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (5 minute)
Systolic blood pressure (mm Hg): Post intubation (10 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (10 minute)
Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Baseline before IV fluid infusion
Diastolic blood pressure (mm Hg): After IV Propofol	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Immediately After IV Propofol
Diastolic blood pressure (mm Hg): At intubation (0 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	At intubation (0 minute)
Diastolic blood pressure (mm Hg): Post intubation (1 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (1 minute)
Diastolic blood pressure (mm Hg): Post intubation (3 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (3 minute)
Diastolic blood pressure (mm Hg): Post intubation (5 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (5 minute)
Diastolic blood pressure (mm Hg): Post intubation (10 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (10 minute)
Mean arterial pressure (mm Hg): Baseline before IV fluid infusion	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Baseline before IV fluid infusion
Mean arterial pressure (mm Hg): After IV Propofol	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Immediately After IV Propofol
Mean arterial pressure (mm Hg): At intubation (0 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	At intubation (0 minute)
Mean arterial pressure (mm Hg): Post intubation (1 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (1 minute)
Mean arterial pressure (mm Hg): Post intubation (3 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (3 minute)
Mean arterial pressure (mm Hg): Post intubation (5 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (5 minute)
Mean arterial pressure (mm Hg): Post intubation (10 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (10 minute)
Units of Measure (e.g., weight and height)	Weight in kilograms, height in meters ( weight and height will be combined to report BMI in kg/m²).	Preanaesthetic checkup, Day 1

Collaborators and Investigators

• Sponsor: National Medical College Birgunj

Publications and helpful links

General Publications

• Smith I, White PF, Nathanson M, Gouldson R. Propofol. An update on its clinical use. Anesthesiology. 1994 Oct;81(4):1005-43. No abstract available.
• Hug CC Jr, McLeskey CH, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, Walawander CA, White PF, Apfelbaum JL, Grasela TH, et al. Hemodynamic effects of propofol: data from over 25,000 patients. Anesth Analg. 1993 Oct;77(4 Suppl):S21-9.
• Van Aken H, Meinshausen E, Prien T, Brussel T, Heinecke A, Lawin P. The influence of fentanyl and tracheal intubation on the hemodynamic effects of anesthesia induction with propofol/N2O in humans. Anesthesiology. 1988 Jan;68(1):157-63. doi: 10.1097/00000542-198801000-00031. No abstract available.
• Briggs LP, Dundee JW, Bahar M, Clarke RS. Comparison of the effect of diisopropyl phenol (ICI 35, 868) and thiopentone on response to somatic pain. Br J Anaesth. 1982 Mar;54(3):307-11. doi: 10.1093/bja/54.3.307.
• McCollum JS, Milligan KR, Dundee JW. The antiemetic action of propofol. Anaesthesia. 1988 Mar;43(3):239-40. doi: 10.1111/j.1365-2044.1988.tb05551.x.
• Williams EL, Hildebrand KL, McCormick SA, Bedel MJ. The effect of intravenous lactated Ringer's solution versus 0.9% sodium chloride solution on serum osmolality in human volunteers. Anesth Analg. 1999 May;88(5):999-1003. doi: 10.1097/00000539-199905000-00006.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 519 - 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No