Clinical trial NCT05777135: Ringer Lactate Preloading on Induction Dose Requirement of Propofol
Official title: Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Ringer's Lactate
Lead sponsor: National Medical College Birgunj
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Propofol dose Required (mg)
timeFrame: Standard dosing in Operation
measure: Total Propofol dose given (mg)
timeFrame: Visualization of loss of eyelash reflex
measure: Loss of eyelash reflex (seconds)
timeFrame: Propofol given till loss of eyelash reflex
Secondary outcomes:
measure: Units of Measure (e.g., weight and height)
timeFrame: Preanaesthetic checkup, Day 1
measure: Heart rate (beats / minute): After IV Propofol
timeFrame: Immediately After IV Propofol
measure: Heart rate (beats / minute): Baseline before IV fluid infusion
timeFrame: Base line Before IV fluid infusion
measure: Heart rate (beats / minute): At intubation (0 minute)
timeFrame: At intubation (0 minute)
measure: Heart rate (beats / minute): Post intubation (1 minute)
timeFrame: Post intubation (1 minute)
measure: Heart rate (beats / minute): Post intubation (3 minute)
timeFrame: Post intubation (3 minute)
measure: Heart rate (beats / minute): Post intubation (5 minute)
timeFrame: Post intubation (5 minute)
measure: Heart rate (beats / minute): Post intubation (10 minute)
timeFrame: Post intubation (10 minute)
measure: Systolic blood pressure (mm Hg): Baseline before IV fluid infusion
timeFrame: Baseline before IV fluid infusion
measure: Systolic blood pressure (mm Hg): After IV Propofol
timeFrame: Immediately After IV Propofol
measure: Systolic blood pressure (mm Hg): At intubation (0 minute)
timeFrame: At intubation (0 minute)
measure: Systolic blood pressure (mm Hg): Post intubation (1 minute)
timeFrame: Post intubation (1 minute)
measure: Systolic blood pressure (mm Hg): Post intubation (3 minute)
timeFrame: Post intubation (3 minute)
measure: Systolic blood pressure (mm Hg): Post intubation (5 minute)
timeFrame: Post intubation (5 minute)
measure: Systolic blood pressure (mm Hg): Post intubation (10 minute)
timeFrame: Post intubation (10 minute)
measure: Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion
timeFrame: Baseline before IV fluid infusion
measure: Diastolic blood pressure (mm Hg): After IV Propofol
timeFrame: Immediately After IV Propofol
measure: Diastolic blood pressure (mm Hg): At intubation (0 minute)
timeFrame: At intubation (0 minute)
measure: Diastolic blood pressure (mm Hg): Post intubation (1 minute)
timeFrame: Post intubation (1 minute)
measure: Diastolic blood pressure (mm Hg): Post intubation (3 minute)
timeFrame: Post intubation (3 minute)
measure: Diastolic blood pressure (mm Hg): Post intubation (5 minute)
timeFrame: Post intubation (5 minute)
measure: Diastolic blood pressure (mm Hg): Post intubation (10 minute)
timeFrame: Post intubation (10 minute)
measure: Mean arterial pressure (mm Hg): After IV Propofol
timeFrame: Immediately After IV Propofol
measure: Mean arterial pressure (mm Hg): Baseline before IV fluid infusion
timeFrame: Baseline before IV fluid infusion
measure: Mean arterial pressure (mm Hg): At intubation (0 minute)
timeFrame: At intubation (0 minute)
measure: Mean arterial pressure (mm Hg): Post intubation (1 minute)
timeFrame: Post intubation (1 minute)
measure: Mean arterial pressure (mm Hg): Post intubation (3 minute)
timeFrame: Post intubation (3 minute)
measure: Mean arterial pressure (mm Hg): Post intubation (5 minute)
timeFrame: Post intubation (5 minute)
measure: Mean arterial pressure (mm Hg): Post intubation (10 minute)
timeFrame: Post intubation (10 minute)
Other outcomes:
Locations:
city: Birgunj
country: Nepal
facility: National Medical College Teaching Hospital
state: Province - 2
Study officials:
References:
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.
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.
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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.
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: 10.1097/00000539-199905000-00006.