Ringer Lactate Preloading on Induction Dose Requirement of Propofol

• Sponsor: National Medical College Birgunj (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05777135
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Ringer's Lactate	Drug: Ringer Lactate prior to surgery and Propofol	Phase 4

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.

1. Then, investigators will visualize for loss of eyelash reflex in both groups.

2. 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.

3. Drug administration and parameters recording will be done by the anaesthesiologist / under supervision

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Heart rate (beats / minute): After IV Propofol [Immediately After IV Propofol]

   Heart rate (beats / minute) will be measured with pulse oxymeter

3. Heart rate (beats / minute): At intubation (0 minute) [At intubation (0 minute)]

   Heart rate (beats / minute) will be measured with pulse oxymeter

4. Heart rate (beats / minute): Post intubation (1 minute) [Post intubation (1 minute)]

   Heart rate (beats / minute) will be measured with pulse oxymeter

5. Heart rate (beats / minute): Post intubation (3 minute) [Post intubation (3 minute)]

   Heart rate (beats / minute) will be measured with pulse oxymeter

6. Heart rate (beats / minute): Post intubation (5 minute) [Post intubation (5 minute)]

   Heart rate (beats / minute) will be measured with pulse oxymeter

7. Heart rate (beats / minute): Post intubation (10 minute) [Post intubation (10 minute)]

   Heart rate (beats / minute) will be measured with pulse oxymeter

8. 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

9. Systolic blood pressure (mm Hg): After IV Propofol [Immediately After IV Propofol]

   Systolic blood pressure (mm Hg) will be recorded on vital monitor

10. Systolic blood pressure (mm Hg): At intubation (0 minute) [At intubation (0 minute)]

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

11. Systolic blood pressure (mm Hg): Post intubation (1 minute) [Post intubation (1 minute)]

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

12. Systolic blood pressure (mm Hg): Post intubation (3 minute) [Post intubation (3 minute)]

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

13. Systolic blood pressure (mm Hg): Post intubation (5 minute) [Post intubation (5 minute)]

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

14. Systolic blood pressure (mm Hg): Post intubation (10 minute) [Post intubation (10 minute)]

    Systolic blood pressure (mm Hg) will be recorded on vital monitor

15. 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

16. Diastolic blood pressure (mm Hg): After IV Propofol [Immediately After IV Propofol]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

17. Diastolic blood pressure (mm Hg): At intubation (0 minute) [At intubation (0 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

18. Diastolic blood pressure (mm Hg): Post intubation (1 minute) [Post intubation (1 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

19. Diastolic blood pressure (mm Hg): Post intubation (3 minute) [Post intubation (3 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

20. Diastolic blood pressure (mm Hg): Post intubation (5 minute) [Post intubation (5 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

21. Diastolic blood pressure (mm Hg): Post intubation (10 minute) [Post intubation (10 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

22. 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

23. Mean arterial pressure (mm Hg): After IV Propofol [Immediately After IV Propofol]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

24. Mean arterial pressure (mm Hg): At intubation (0 minute) [At intubation (0 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

25. Mean arterial pressure (mm Hg): Post intubation (1 minute) [Post intubation (1 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

26. Mean arterial pressure (mm Hg): Post intubation (3 minute) [Post intubation (3 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

27. Mean arterial pressure (mm Hg): Post intubation (5 minute) [Post intubation (5 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

28. Mean arterial pressure (mm Hg): Post intubation (10 minute) [Post intubation (10 minute)]

    Diastolic blood pressure (mm Hg) will be recorded on vital monitor

Secondary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Arushi Jaiswal	Birgunj	Province - 2	Nepal	44300

Sponsors and Collaborators

• National Medical College Birgunj

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arushi Jaiswal, Postgraduate Doctor, National Medical College Birgunj
• ClinicalTrials.gov Identifier: NCT05777135
• Other Study ID Numbers: 519 - 2022
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 27, 2023
• Last Verified: Mar 1, 2023

• 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
• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of Mar 27, 2023