Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05940649
Other study ID # 2023-100999-BO-ff
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 3, 2023
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source Universitätsklinikum Hamburg-Eppendorf
Contact Kristen Thomsen, MD
Phone +4915222818167
Email kr.thomsen@uke.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. About one third of intraoperative hypotension occurs during anesthetic induction - i.e., between the start of anesthetic induction and surgical incision. Hypotension during anesthetic induction is associated with postoperative acute kidney injury. Unmodifiable risk factors for hypotension during anesthetic induction include age, male sex, and a high American Society of Anesthesiologists physical status class. However, hypotension during anesthetic induction is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation. In most German hospitals, norepinephrine is the first-line vasopressor to treat hypotension during anesthetic induction. Norepinephrine is usually given as repeated manual boluses of 5, 10, or 20 μg. The continuous administration of norepinephrine via a perfusion pump is usually started only later. It remains unknown whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction. We thus propose to investigate whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction in non-cardiac surgery patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 262
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - non-cardiac surgery - >45 years of age - American Society of Anesthesiologists physical status classification II, III, and IV. Exclusion Criteria: - Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter - Emergency surgery - Transplant surgery - History of organ transplant - Pregnancy - Heart rhythms other than sinus rhythm - Impossible Finger-cuff blood pressure monitoring - Rapid sequence induction

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Continuous norepinephrine administration
In patients randomized to continuous norepinephrine administration, hypotension (= mean arterial pressure < 65mmHg) will be treated with continuous norepinephrine infusion. The norepinephrine perfusion line will be connected to the saline infusion line using a three-way valve. Treating anesthesiologists will be free to reduce or increase the norepinephrine infusion rate anytime.

Locations

Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypotension during anesthetic induction Area under a MAP of 65 mmHg [mmHg x min] First 15 minutes of anesthetic induction
Secondary Hypotension during anesthetic induction Area under a MAP of 60, 50, and 40 mmHg [mmHg x min] First 15 minutes of anesthetic induction
Secondary Hypotension during anesthetic induction Duration of a MAP <65, <60, <50, and <40 mmHg [min] First 15 minutes of anesthetic induction
Secondary Hypertension during anesthetic induction Duration of a MAP >100, >110, >120, and >140 mmHg [min] First 15 minutes of anesthetic induction
Secondary Hypertension during anesthetic induction Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min] First 15 minutes of anesthetic induction
Secondary Hypertension during anesthetic induction Absolute [n] and relative [%] number of patients with any MAP measurement >100, >110, >120 and >140 mmHg First 15 minutes of anesthetic induction
Secondary Hypotension during anesthetic induction Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg First 15 minutes of anesthetic induction
Secondary Hypotension during anesthetic induction Absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg First 15 minutes of anesthetic induction
Secondary Hypotension during anesthetic induction Cumulative dose of norepinephrine indexed to body weight [µg kg-1] First 15 minutes of anesthetic induction
See also
  Status Clinical Trial Phase
Completed NCT04519203 - The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery N/A
Recruiting NCT05011357 - Phenylephrine and Pulse Pressure Variability Early Phase 1
Completed NCT04025086 - Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position
Completed NCT03965793 - Individualized Fluid And Vasopressor Administration In Surgical Patients N/A
Completed NCT05101590 - Hypotension Decision Assist - Use, Safety and Efficacy N/A
Recruiting NCT05557253 - Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery N/A
Completed NCT04547491 - Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery N/A
Completed NCT03376347 - Intraoperative Implementation of the Hypotension Probability Indicator N/A
Recruiting NCT06091904 - Effects of Sufentanil on the Intraoperative Hemodynamics N/A
Recruiting NCT04120012 - The Effect of Frailty to Perioperative Complications in the Elderly
Recruiting NCT06202638 - Hypotension Prediction Index (HPI) in Lung Resections
Completed NCT04301102 - The Predict H Trial N/A
Completed NCT05671783 - Intraoperative Hypotension and Post-anesthesia Care Unit Recovery
Completed NCT05821647 - Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission N/A
Recruiting NCT04872504 - Hypotension Prediction Index in Patients Undergoing Liver Transplantation N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury
Recruiting NCT05637606 - HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery N/A
Completed NCT03889730 - Intraoperative Hypotension and Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery
Completed NCT03442907 - Personalized Blood Pressure Management N/A
Recruiting NCT03795831 - Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use