NorepinephrineNCT05637164
Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery
A study testing norepinephrine bitartrate in people with Norepinephrine and Post-induction Hypotension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Norepinephrine, Post-induction Hypotension
- What is being tested?
- norepinephrine bitartrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 May 2023
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 to 80 years
- Undergoing major abdominal surgery
- American Society of Anesthesiologists (ASA) physical status of I/II/III
Who cannot join
- Patient refusal
- Severe untreated or uncontrolled hypertension despite medications
- Bradycardia (heart rate < 50 beat per minute)
- Cardiac morbidities, heart block greater than the first degree
- Severe hepatic and renal dysfunction
- hyperthyroidism
Show all 9Show fewer
- vascular diseases
- BMI>30
- Monoamine oxidase inhibitors were used 2 weeks before surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 13757118632, zryanmin@zju.edu.cn
About this study
Official title: Second Affiliated Hosptial， School of Medicine, ZheJiang University
The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is:
What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients.
Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.
- Conditions
- Norepinephrine, Post-induction Hypotension
- Being tested
- norepinephrine bitartrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norepinephrine bitartrateDrug
The treatment group will receive a continuous infusion of norepinephrine at the beginning of anesthesia induction until 15 minutes after intubation. The dosage of norepinephrine was decided by the up-and-down sequential allocation method with an initial dose of 0.05 µg/kg/min and a 0.005 µg/kg/min gradient.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Experimental | Not described Receives: Drug: norepinephrine bitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure
Measured: 15 minutes after intubation
Secondary outcomes (2)
incidence of bradycardia
heart rate less than 50 beat per minute
Measured: 15 minutes after intubation
incidence of reactive hypertension
increased mean arterial pressure by > 20% of the baseline reading
Measured: 15 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NorepinephrineStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637164
- Sponsor's protocol ID
- 2022-0950
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 5 Dec 2022
- 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 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Affiliated Hosptial， School of Medicine, ZheJiang University
- ClinicalTrials.gov ID
- NCT05637164
- Acronym / sponsor ID
- 2022-0950
- Conditions
- Norepinephrine, Post-induction Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 5 Dec 2022 (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.
The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is:
What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients.
Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Experimental | Drug: norepinephrine bitartrate |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged 65 to 80 years
- Undergoing major abdominal surgery
- American Society of Anesthesiologists (ASA) physical status of I/II/III
Key exclusion criteria (9 listed)
- Patient refusal
- Severe untreated or uncontrolled hypertension despite medications
- Bradycardia (heart rate < 50 beat per minute)
- Cardiac morbidities, heart block greater than the first degree
- Severe hepatic and renal dysfunction
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 |
|---|---|---|
| norepinephrine bitartrateThe treatment group will receive a continuous infusion of norepinephrine at the beginning of anesthesia induction until 15 minutes after intubation. The dosage of norepinephrine was decided by the up-and-down sequential allocation method with an initial dose of 0.05 µg/kg/min and a 0.005 µg/kg/min gradient. | Drug | Norepinephrine |
Primary outcome
Incidence of hypotension
Time frame: 15 minutes after intubation
less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure
2 secondary outcomes
incidence of bradycardia
Time frame: 15 minutes after intubation
incidence of reactive hypertension
Time frame: 15 minutes after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Norepinephrine
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
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 study testing norepinephrine bitartrate in people with Norepinephrine and Post-induction Hypotension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 9 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 Dec 2022. 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 China. 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 Min Yan, Doctor (13757118632, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: 15 minutes after intubation). 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 5 Dec 2022.