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Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery

Second Affiliated Hosptial, School of Medicine, ZheJiang University

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05637164
Enrollment
40
Registered
2022-12-05
Start date
2022-12-01
Completion date
2023-05-30
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Norepinephrine, Post-induction Hypotension

Brief 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 . 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.

Interventions

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* aged 65 to 80 years * Undergoing major abdominal surgery * American Society of Anesthesiologists (ASA) physical status of I/II/III

Exclusion criteria

* 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 * vascular diseases * BMI\>30 * Monoamine oxidase inhibitors were used 2 weeks before surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypotension15 minutes after intubationless than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure

Secondary

MeasureTime frameDescription
incidence of bradycardia15 minutes after intubationheart rate less than 50 beat per minute
incidence of reactive hypertension15 minutes after intubationincreased mean arterial pressure by \> 20% of the baseline reading

Countries

China

Contacts

Primary ContactMin Yan, Doctor
zryanmin@zju.edu.cn13757118632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026