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

Not Applicable

Recruiting

• Conditions: Norepinephrine; Post-induction Hypotension
• Interventions: Drug: norepinephrine bitartrate

• Registration Number: NCT05637164
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study Start: 2022-12-01
• Study First Posted: 2022-12-05
• Last Update Posted: 2022-12-05
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Norepinephrine	norepinephrine bitartrate	-

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	15 minutes after intubation	less than 80% baseline blood pressure less than 80% baseline blood pressure less than 80% baseline blood pressure

Secondary Outcome Measures

Name	Time	Method
incidence of reactive hypertension	15 minutes after intubation	increased mean arterial pressure by \> 20% of the baseline reading
incidence of bradycardia	15 minutes after intubation	heart rate less than 50 beat per minute

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China