Ringer Lactate Preloading on Induction Dose Requirement of Propofol

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777135
• Other study ID #: 519 - 2022
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: National Medical College Birgunj
• Contact: Dr Arushi Jaiswal
• Phone: +9779841675096
• Email: arushij.dr16[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Ringer's Lactate

Intervention

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

Locations

Country	Name	City	State
Nepal	National Medical College Teaching Hospital	Birgunj	Province - 2

Sponsors (1)

Lead Sponsor	Collaborator
National Medical College Birgunj

Country where clinical trial is conducted

Nepal, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.1097/00000 — View Citation

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: 10.1097/00000539-199905000-0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propofol dose Required (mg)	Propofol dose (mg) with aspect to weight (kg)	Standard dosing in Operation
Primary	Total Propofol dose given (mg)	Propofol dose (mg)	Visualization of loss of eyelash reflex
Primary	Loss of eyelash reflex (seconds)	Visualization of loss of eyelash reflex (seconds)	Propofol given till loss of eyelash reflex
Secondary	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
Secondary	Heart rate (beats / minute): After IV Propofol	Heart rate (beats / minute) will be measured with pulse oxymeter	Immediately After IV Propofol
Secondary	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
Secondary	Heart rate (beats / minute): At intubation (0 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	At intubation (0 minute)
Secondary	Heart rate (beats / minute): Post intubation (1 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (1 minute)
Secondary	Heart rate (beats / minute): Post intubation (3 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (3 minute)
Secondary	Heart rate (beats / minute): Post intubation (5 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (5 minute)
Secondary	Heart rate (beats / minute): Post intubation (10 minute)	Heart rate (beats / minute) will be measured with pulse oxymeter	Post intubation (10 minute)
Secondary	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
Secondary	Systolic blood pressure (mm Hg): After IV Propofol	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Immediately After IV Propofol
Secondary	Systolic blood pressure (mm Hg): At intubation (0 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	At intubation (0 minute)
Secondary	Systolic blood pressure (mm Hg): Post intubation (1 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (1 minute)
Secondary	Systolic blood pressure (mm Hg): Post intubation (3 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (3 minute)
Secondary	Systolic blood pressure (mm Hg): Post intubation (5 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (5 minute)
Secondary	Systolic blood pressure (mm Hg): Post intubation (10 minute)	Systolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (10 minute)
Secondary	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
Secondary	Diastolic blood pressure (mm Hg): After IV Propofol	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Immediately After IV Propofol
Secondary	Diastolic blood pressure (mm Hg): At intubation (0 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	At intubation (0 minute)
Secondary	Diastolic blood pressure (mm Hg): Post intubation (1 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (1 minute)
Secondary	Diastolic blood pressure (mm Hg): Post intubation (3 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (3 minute)
Secondary	Diastolic blood pressure (mm Hg): Post intubation (5 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (5 minute)
Secondary	Diastolic blood pressure (mm Hg): Post intubation (10 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (10 minute)
Secondary	Mean arterial pressure (mm Hg): After IV Propofol	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Immediately After IV Propofol
Secondary	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
Secondary	Mean arterial pressure (mm Hg): At intubation (0 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	At intubation (0 minute)
Secondary	Mean arterial pressure (mm Hg): Post intubation (1 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (1 minute)
Secondary	Mean arterial pressure (mm Hg): Post intubation (3 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (3 minute)
Secondary	Mean arterial pressure (mm Hg): Post intubation (5 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (5 minute)
Secondary	Mean arterial pressure (mm Hg): Post intubation (10 minute)	Diastolic blood pressure (mm Hg) will be recorded on vital monitor	Post intubation (10 minute)