Post Induction HypotensionNCT05924230
Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension
A study testing RL 10ml/kg and RL 15ml/kg in people with Post Induction Hypotension, run by Tata Main Hospital at 1 site in India.
Trial summary
To assess the dose responsiveness of ringer lactate solution in prevention of post-induction hypotension predicted by Ultrasound guided Inferior Vena Cava diameter in patients receiving General anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Induction Hypotension
- What is being tested?
- RL 10ml/kg and RL 15ml/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2023to 31 Aug 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective surgery under General anesthesia
Who cannot join
- Age <18 and > 65 American Society of Anesthesiologists (ASA) Physical status classification system group III and IV Systolic blood pressure ≥ 180 mmHg Systolic blood pressure < 90 mmHg Pregnant women Patients with abdominal mass or ascites Emergency surgery
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Abhishek Chatterjee
Jamshedpur, Jharkhand, 831001
Abhishek Chatterjee, +917763807075, dr.abhishek@tatasteel.com
About this study
Official title: Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension Predicted by Inferior Vena Cava Collapsibility Index in Patients Receiving General Anesthesia
To assess the dose responsiveness of ringer lactate solution in prevention of post-induction hypotension predicted by Ultrasound guided Inferior Vena Cava diameter in patients receiving General anesthesia.
OBJECTIVES Primary - To find the optimum preloading dosage of Ringer Lactate to prevent post induction hypotension.
Secondary - To find the predictive incidence of Post-induction hypotension according to age, gender, type of surgery and comorbidities.
Read the detailed description
All patients, after Ultrasonographic Inferior vena cava collapsibility index calculation, will receive Lactated Ringer's solution as per body weight and as per their allocated group in the receiving area.
After induction inside the Operating Room, All patients will be monitored continuously using Electrocardiography, pulse oximetry, noninvasive Blood pressure measurement and capnography .
Heart rate, Systolic - Diastolic - Mean blood pressure, Oxygen saturation will be monitored as follows :
- Baseline parameters - Prior to administration of intravenous Ringer's lactate solution
- T0 (after administration of intravenous Ringer's lactate solution but prior to induction of anaesthesia),
- T1-T10 (every minute for first 10 mins after induction of anaesthesia) Our institutional standard practice of induction of Anaesthesia with Fentanyl (2 μg/kg), Propofol (2 mg/kg) and Vecuronium (0.1mg/kg ) will be followed and intubation will be done only after first 10 mins post induction.
Amount of Mephentermine needed to correct hypotension despite RL infusion will also be calculated.
- Conditions
- Post Induction Hypotension
- Being tested
- RL 10ml/kg, RL 15ml/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RL 10ml/kgOther
Inferior vena cava collapsibility index of all patients will be calculated by ultrasonography and if it is >50%, then patients of this group (Group 1) will receive Ringer's lactate 10ml/kg before induction in the receiving area
RL 15ml/kgOther
Inferior vena cava collapsibility index of all patients will be calculated by ultrasonography and if it is >50%, then patients of this group (Group 2) will receive Ringer's lactate 15ml/kg before induction in the receiving area
| Study group | Role | What they receive |
|---|---|---|
| RL 10 | Active comparator | Patients of this group will receive Ringer's lactate (RL) 10ml/kg Receives: Other: RL 10ml/kg |
| RL 15 | Active comparator | Patients of this group will receive 15ml/kg of Ringer's lactate solution Receives: Other: RL 15ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective dose of Ringer's lactate solution to prevent post-induction hypotension
This study will try to find out the effective dose of Ringer's lactate solution in ml/Kg that will prevent hypotension after induction of anaesthesia in study population
Measured: 15 months
Secondary outcomes (1)
Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension
This study will try to find out the effect of age, gender, type of surgery and type of comorbid conditions (like Diabetes, Hypertension etc) on occurence of post-induction hypotension by measuring the % of hypotension in these categories of patients
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Induction HypotensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Main Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhishek Chatterjee, Tata Main Hospital
- Investigators
- Abhishek Chatterjee, Principal investigator, Tata Steel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924230
- Sponsor's protocol ID
- TMH/IEC/JUNE/011/2022
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension Predicted by Inferior Vena Cava Collapsibility Index in Patients Receiving General Anesthesia
- ClinicalTrials.gov ID
- NCT05924230
- Acronym / sponsor ID
- TMH/IEC/JUNE/011/2022
- Conditions
- Post Induction Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tata Main HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 29 Jun 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 assess the dose responsiveness of ringer lactate solution in prevention of post-induction hypotension predicted by Ultrasound guided Inferior Vena Cava diameter in patients receiving General anesthesia.
OBJECTIVES Primary - To find the optimum preloading dosage of Ringer Lactate to prevent post induction hypotension.
Secondary - To find the predictive incidence of Post-induction hypotension according to age, gender, type of surgery and comorbidities.
Detailed description
All patients, after Ultrasonographic Inferior vena cava collapsibility index calculation, will receive Lactated Ringer's solution as per body weight and as per their allocated group in the receiving area.
After induction inside the Operating Room, All patients will be monitored continuously using Electrocardiography, pulse oximetry, noninvasive Blood pressure measurement and capnography .
Heart rate, Systolic - Diastolic - Mean blood pressure, Oxygen saturation will be monitored as follows :
- Baseline parameters - Prior to administration of intravenous Ringer's lactate solution
- T0 (after administration of intravenous Ringer's lactate solution but prior to induction of anaesthesia),
- T1-T10 (every minute for first 10 mins after induction of anaesthesia) Our institutional standard practice of induction of Anaesthesia with Fentanyl (2 μg/kg), Propofol (2 mg/kg) and Vecuronium (0.1mg/kg ) will be followed and intubation will be done only after first 10 mins post induction.
Amount of Mephentermine needed to correct hypotension despite RL infusion will also be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RL 10 | Active comparator | Other: RL 10ml/kgPatients of this group will receive Ringer's lactate (RL) 10ml/kg |
| RL 15 | Active comparator | Other: RL 15ml/kgPatients of this group will receive 15ml/kg of Ringer's lactate solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective surgery under General anesthesia
Key exclusion criteria (1 listed)
- Age <18 and > 65 American Society of Anesthesiologists (ASA) Physical status classification system group III and IV Systolic blood pressure ≥ 180 mmHg Systolic blood pressure < 90 mmHg Pregnant women Patients with abdominal mass or ascites Emergency surgery
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 |
|---|---|---|
| RL 10ml/kgInferior vena cava collapsibility index of all patients will be calculated by ultrasonography and if it is >50%, then patients of this group (Group 1) will receive Ringer's lactate 10ml/kg before induction in the receiving area | Other | RL 10 |
| RL 15ml/kgInferior vena cava collapsibility index of all patients will be calculated by ultrasonography and if it is >50%, then patients of this group (Group 2) will receive Ringer's lactate 15ml/kg before induction in the receiving area | Other | RL 15 |
Primary outcome
Effective dose of Ringer's lactate solution to prevent post-induction hypotension
Time frame: 15 months
This study will try to find out the effective dose of Ringer's lactate solution in ml/Kg that will prevent hypotension after induction of anaesthesia in study population
1 secondary outcome
Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Abhishek Chatterjee principal investigator
Tata Steel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RL 10ml/kg and RL 15ml/kg in people with Post Induction Hypotension, run by Tata Main Hospital at 1 site in India.
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 1 inclusion and 1 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 29 Jun 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 India. 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.
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 Chatterjee (+917763807075, dr.abhishek@tatasteel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective dose of Ringer's lactate solution to prevent post-induction hypotension (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.