Ringer Lactate Preloading on Induction Dose Requirement of Propofol

NCT ID: NCT05777135

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Ringer's Lactate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Ringer Lactate prior to surgery and Propofol

Intervention Type DRUG

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

Group II (No preloading)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ringer Lactate prior to surgery and Propofol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ringer Lactate group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Medical College Birgunj

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Arushi Jaiswal

Postgraduate Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Medical College Teaching Hospital

Birgunj, Madhesh, Nepal

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Nepal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr Arushi Jaiswal

Role: CONTACT

+9779841675096

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr Arushi Jaiswal

Role: primary

+9779841675096

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 7943815 (View on PubMed)

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.

Reference Type RESULT
PMID: 8214693 (View on PubMed)

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.

Reference Type RESULT
PMID: 3257362 (View on PubMed)

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.

Reference Type RESULT
PMID: 6978144 (View on PubMed)

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.

Reference Type RESULT
PMID: 3259081 (View on PubMed)

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.

Reference Type RESULT
PMID: 10320158 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

519 - 2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.