A Randomized Open Label, Parallel Group Study to Evaluate the Hemodynamic Effects of Cafedrine/Theodrenaline vs Noradrenaline in the Treatment of Intraoperative Arterial Hypotension in Adults after Induction of General Anesthesia.

Phase 3

• Conditions: I95.2; I95.9; Hypotension due to drugs; Hypotension, unspecified

• Registration Number: DRKS00028589
• Lead Sponsor: TEVA-ratiopharm GmbH Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

undergoing elective vascular surgery
require arterial cannulation
require advanced hemodynamic monitoring prior to induction of general anesthesia
require antihypotensive drug treatment due to arterial hypotension

Exclusion Criteria

a. The patient has a known hypersensitivity to any components of the IMPs stated in this protocol;
b. The patient has a known hypersensitivity to sodium metabisulfite;
c. The patient has bronchial asthma with sulfite hypersensitivity;
d. The patient has diagnosis of clinical relevant mitral stenosis;
e. The patient has diagnosis of clinical relevant aortic stenosis;
f. The patient has a diagnosis of hyperthyroidism;
g. The patient has a diagnosis of pheochromocytoma;
h. The patient is going to receive any cardiac sensitizing agent (e.g. cyclopropane or halothane) or is going to have deep hypoxia or hypercapnia concomitant to application of IMP;
i. The patient has uncontrolled hypertension as co-morbidity;
j. The patient has sepsis, septic shock, or systemic inflammatory response syndrome (SIRS)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endpoint 1:<br>Group difference in mean MAP [DaMAP] during the infusion phase, calculated as the mean difference between areas below the target MAP value (90 mmHg). Deviations below (<90mmHg) within the 20-minute observation period are summed up.<br>Non-inferiority is assumed if DaMAP is below the non-inferiority limit (5 mmHg) with a unilateral alpha level of 0.025.<br><br>Only in the case of non-inferiority the following hypothesis will be tested in a sequential test order:<br><br>Endpoint 2:<br>Treatment related difference in mean cardiac index [DaCI] during the bolus phase (0-20 minutes after the first event of arterial hypotension), calculated as the difference in the means of individual areas above the CImin, where CImin is individually defined as the mean of three measurements directly obtained prior to induction of anesthesia Superiority is concluded if a positive DaCI at a one-sided alpha level of 0.025 can be demonstrated.

Secondary Outcome Measures

Name	Time	Method
1) Treatment related difference in average MAP during study phase 1 (0-20 minutes after occurrence of first hypotensive episode requiring medication):<br>2) Treatment related differences in:<br>a. change in HR<br>b. change in SVI<br>c. change in SVRI<br>d. change of dP/dtmax<br>during study phase 1<br>3) the ratio of treatment specific incidence rates of overshooting blood pressure (MAP ?110 mmHg) events during study phase 1.<br>4) the ratio of treatment specific incidence rates of low blood pressure (MAP <80 mmHg) events during study phase 1.<br>5) Treatment related differences in number of:<br>a. additional bolus-injections (at MAP <70 mmHg)<br>b. additional measures (volume, position changes etc.)<br>required to stabilize blood pressure during study phase 1.