Ringer Lactate Preloading on Induction Dose Requirement of Propofol

Phase 4

Recruiting

• Conditions: Anesthesia; Ringer's Lactate
• Interventions: Drug: Ringer Lactate prior to surgery and Propofol

• Registration Number: NCT05777135
• Lead Sponsor: National Medical College Birgunj

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

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-03-18
• Study First Posted: 2023-03-21
• Status Verified: 2023-04
• Study Start: 2023-04-01
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Preloading with Ringer Lactate)	Ringer Lactate prior to surgery and Propofol	Preloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Medical College Teaching Hospital; 🇳🇵 Birgunj, Province - 2, Nepal