AnesthesiaPhase 4NCT05777135
Ringer Lactate Preloading on Induction Dose Requirement of Propofol
A Phase 4 study testing Ringer Lactate prior to surgery and Propofol in people with Anesthesia and Ringer's Lactate, run by National Medical College Birgunj at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Ringer's Lactate
- What is being tested?
- Ringer Lactate prior to surgery and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2023to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for elective surgeries
- American Society of Anaesthesiologists (ASA) class I patients
- Age between 18-45 years
- Any surgery under general anaesthesia requiring endotracheal intubation
- Body mass index (BMI) -18.5 - 24.9
- Those providing written consent
Who cannot join
- Emergency surgery
- Patients with multiple injuries, pregnancy
- Airway Mallampati grade II, III and IV
- Allergy to Ringer Lactate and Propofol.
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
National Medical College Teaching Hospital
Birgunj, Madhesh, 44300
Dr Arushi Jaiswal, +9779841675096, arushij.dr16@gmail.com
About this study
Official title: Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center
- 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.
Read the detailed description
- From the operation list, patients that meet the Inclusion criteria will be selected. (n=60)
- 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.
- 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.
- Then, investigators will visualize for loss of eyelash reflex in both groups.
- 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.
- Drug administration and parameters recording will be done by the anaesthesiologist / under supervision
- Conditions
- Anesthesia, Ringer's Lactate
- Being tested
- Ringer Lactate prior to surgery and Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer Lactate prior to surgery and PropofolDrug
Also called Ringer Lactate group
Ringer Lactate prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted
| Study group | Role | What they receive |
|---|---|---|
| Group I (Preloading with Ringer Lactate) | Experimental | Preloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted Receives: Drug: Ringer Lactate prior to surgery and Propofol |
| Group II (No preloading) | No intervention | No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol dose Required (mg)
Propofol dose (mg) with aspect to weight (kg)
Measured: Standard dosing in Operation
Total Propofol dose given (mg)
Propofol dose (mg)
Measured: Visualization of loss of eyelash reflex
Loss of eyelash reflex (seconds)
Visualization of loss of eyelash reflex (seconds)
Measured: Propofol given till loss of eyelash reflex
Secondary outcomes (29)
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).
Measured: Preanaesthetic checkup, Day 1
Heart rate (beats / minute): After IV Propofol
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: Immediately After IV Propofol
Heart rate (beats / minute): Baseline before IV fluid infusion
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: Base line Before IV fluid infusion
Heart rate (beats / minute): At intubation (0 minute)
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: At intubation (0 minute)
Heart rate (beats / minute): Post intubation (1 minute)
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: Post intubation (1 minute)
Heart rate (beats / minute): Post intubation (3 minute)
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: Post intubation (3 minute)
Heart rate (beats / minute): Post intubation (5 minute)
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: Post intubation (5 minute)
Heart rate (beats / minute): Post intubation (10 minute)
Heart rate (beats / minute) will be measured with pulse oxymeter
Measured: Post intubation (10 minute)
Systolic blood pressure (mm Hg): Baseline before IV fluid infusion
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Baseline before IV fluid infusion
Systolic blood pressure (mm Hg): After IV Propofol
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Immediately After IV Propofol
Systolic blood pressure (mm Hg): At intubation (0 minute)
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: At intubation (0 minute)
Systolic blood pressure (mm Hg): Post intubation (1 minute)
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (1 minute)
Systolic blood pressure (mm Hg): Post intubation (3 minute)
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (3 minute)
Systolic blood pressure (mm Hg): Post intubation (5 minute)
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (5 minute)
Systolic blood pressure (mm Hg): Post intubation (10 minute)
Systolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (10 minute)
Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Baseline before IV fluid infusion
Diastolic blood pressure (mm Hg): After IV Propofol
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Immediately After IV Propofol
Diastolic blood pressure (mm Hg): At intubation (0 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: At intubation (0 minute)
Diastolic blood pressure (mm Hg): Post intubation (1 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (1 minute)
Diastolic blood pressure (mm Hg): Post intubation (3 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (3 minute)
Diastolic blood pressure (mm Hg): Post intubation (5 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (5 minute)
Diastolic blood pressure (mm Hg): Post intubation (10 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (10 minute)
Mean arterial pressure (mm Hg): After IV Propofol
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Immediately After IV Propofol
Mean arterial pressure (mm Hg): Baseline before IV fluid infusion
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Baseline before IV fluid infusion
Mean arterial pressure (mm Hg): At intubation (0 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: At intubation (0 minute)
Mean arterial pressure (mm Hg): Post intubation (1 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (1 minute)
Mean arterial pressure (mm Hg): Post intubation (3 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (3 minute)
Mean arterial pressure (mm Hg): Post intubation (5 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (5 minute)
Mean arterial pressure (mm Hg): Post intubation (10 minute)
Diastolic blood pressure (mm Hg) will be recorded on vital monitor
Measured: Post intubation (10 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical College Birgunj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arushi Jaiswal, National Medical College Birgunj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777135
- Sponsor's protocol ID
- 519 - 2022
- Status last verified
- Apr 2023
- First submitted
- 1 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 7943815Hug 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.
PubMed 8214693Van 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.
PubMed 3257362Briggs 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.
PubMed 6978144McCollum 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.
PubMed 3259081Williams 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.
PubMed 10320158
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center
- ClinicalTrials.gov ID
- NCT05777135
- Acronym / sponsor ID
- 519 - 2022
- Conditions
- Anesthesia, Ringer's Lactate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Medical College BirgunjUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- From the operation list, patients that meet the Inclusion criteria will be selected. (n=60)
- 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.
- 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.
- Then, investigators will visualize for loss of eyelash reflex in both groups.
- 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.
- Drug administration and parameters recording will be done by the anaesthesiologist / under supervision
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Preloading with Ringer Lactate) | Experimental | Drug: Ringer Lactate prior to surgery and PropofolPreloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted |
| Group II (No preloading) | No intervention | –No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients scheduled for elective surgeries
- American Society of Anaesthesiologists (ASA) class I patients
- Age between 18-45 years
- Any surgery under general anaesthesia requiring endotracheal intubation
- Body mass index (BMI) -18.5 - 24.9
Key exclusion criteria (4 listed)
- Emergency surgery
- Patients with multiple injuries, pregnancy
- Airway Mallampati grade II, III and IV
- Allergy to Ringer Lactate and Propofol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer Lactate prior to surgery and PropofolAlso: Ringer Lactate groupRinger Lactate prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted | Drug | Group I (Preloading with Ringer Lactate) |
Primary outcome
Propofol dose Required (mg)
Time frame: Standard dosing in Operation
Propofol dose (mg) with aspect to weight (kg)
Total Propofol dose given (mg)
Time frame: Visualization of loss of eyelash reflex
Propofol dose (mg)
Loss of eyelash reflex (seconds)
Time frame: Propofol given till loss of eyelash reflex
Visualization of loss of eyelash reflex (seconds)
29 secondary outcomes
Units of Measure (e.g., weight and height)
Time frame: Preanaesthetic checkup, Day 1
Heart rate (beats / minute): After IV Propofol
Time frame: Immediately After IV Propofol
Heart rate (beats / minute): Baseline before IV fluid infusion
Time frame: Base line Before IV fluid infusion
Heart rate (beats / minute): At intubation (0 minute)
Time frame: At intubation (0 minute)
Heart rate (beats / minute): Post intubation (1 minute)
Time frame: Post intubation (1 minute)
Heart rate (beats / minute): Post intubation (3 minute)
Time frame: Post intubation (3 minute)
Heart rate (beats / minute): Post intubation (5 minute)
Time frame: Post intubation (5 minute)
Heart rate (beats / minute): Post intubation (10 minute)
Time frame: Post intubation (10 minute)
Systolic blood pressure (mm Hg): Baseline before IV fluid infusion
Time frame: Baseline before IV fluid infusion
Systolic blood pressure (mm Hg): After IV Propofol
Time frame: Immediately After IV Propofol
Systolic blood pressure (mm Hg): At intubation (0 minute)
Time frame: At intubation (0 minute)
Systolic blood pressure (mm Hg): Post intubation (1 minute)
Time frame: Post intubation (1 minute)
Systolic blood pressure (mm Hg): Post intubation (3 minute)
Time frame: Post intubation (3 minute)
Systolic blood pressure (mm Hg): Post intubation (5 minute)
Time frame: Post intubation (5 minute)
Systolic blood pressure (mm Hg): Post intubation (10 minute)
Time frame: Post intubation (10 minute)
Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion
Time frame: Baseline before IV fluid infusion
Diastolic blood pressure (mm Hg): After IV Propofol
Time frame: Immediately After IV Propofol
Diastolic blood pressure (mm Hg): At intubation (0 minute)
Time frame: At intubation (0 minute)
Diastolic blood pressure (mm Hg): Post intubation (1 minute)
Time frame: Post intubation (1 minute)
Diastolic blood pressure (mm Hg): Post intubation (3 minute)
Time frame: Post intubation (3 minute)
Diastolic blood pressure (mm Hg): Post intubation (5 minute)
Time frame: Post intubation (5 minute)
Diastolic blood pressure (mm Hg): Post intubation (10 minute)
Time frame: Post intubation (10 minute)
Mean arterial pressure (mm Hg): After IV Propofol
Time frame: Immediately After IV Propofol
Mean arterial pressure (mm Hg): Baseline before IV fluid infusion
Time frame: Baseline before IV fluid infusion
Mean arterial pressure (mm Hg): At intubation (0 minute)
Time frame: At intubation (0 minute)
Mean arterial pressure (mm Hg): Post intubation (1 minute)
Time frame: Post intubation (1 minute)
Mean arterial pressure (mm Hg): Post intubation (3 minute)
Time frame: Post intubation (3 minute)
Mean arterial pressure (mm Hg): Post intubation (5 minute)
Time frame: Post intubation (5 minute)
Mean arterial pressure (mm Hg): Post intubation (10 minute)
Time frame: Post intubation (10 minute)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Results publication: PubMed 7943815Smith I, White PF, Nathanson M, Gouldson R. Propofol. An update on its clinical use. Anesthesiology. 1994 Oct;81(4):1005-43. No abstract available.
- Results publication: PubMed 8214693Hug 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.
- Results publication: PubMed 3257362Van 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.
- Results publication: PubMed 6978144Briggs 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.
- Results publication: PubMed 3259081McCollum 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.
- Results publication: PubMed 10320158Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ringer Lactate prior to surgery and Propofol in people with Anesthesia and Ringer's Lactate, run by National Medical College Birgunj at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Arushi Jaiswal (+9779841675096, arushij.dr16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol dose Required (mg) (time frame: Standard dosing in Operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777135, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.