Ringer Lactate Preloading on Induction Dose Requirement of Propofol

NCT05777135 | Unknown Phase 4 DMC

• 1 other identifier: 519 - 2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Ringer's Lactate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (29)

• Units of Measure (e.g., weight and height)

  Preanaesthetic checkup, Day 1

• Heart rate (beats / minute): After IV Propofol

  Immediately After IV Propofol

• Heart rate (beats / minute): Baseline before IV fluid infusion

  Base line Before IV fluid infusion

• Heart rate (beats / minute): At intubation (0 minute)

  At intubation (0 minute)

• Heart rate (beats / minute): Post intubation (1 minute)

  Post intubation (1 minute)

Study Arms (2)

Group I (Preloading with Ringer Lactate)

EXPERIMENTAL

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

Group II (No preloading)

NO INTERVENTION

No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted

Interventions

Ringer Lactate prior to surgery and Propofol DRUG

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

Also known as: Ringer Lactate group

Group I (Preloading with Ringer Lactate)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Medical College Birgunj: lead

Study Sites (1)

National Medical College Teaching Hospital

Birgunj, Madhesh, 44300, Nepal

RECRUITING

Related Publications (6)

• 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.

  PMID: 7943815 RESULT

• 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.

  PMID: 8214693 RESULT

• 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.

  PMID: 3257362 RESULT

• 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.

  PMID: 6978144 RESULT

• 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.

  PMID: 3259081 RESULT

• 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.

  PMID: 10320158 RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Dr Arushi Jaiswal

CONTACT

+9779841675096; arushij.dr16@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Doctor

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 21, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

NE (1)