Kasr Alainy Hospital
Cairo, 11562, Egypt
NCT Number: NCT07077265
The current study aims to determine whether norepinephrine infusion rate (0.07 mcg/kg/min) is non-inferior to the higher dose (0.1 mcg/kg/min) in maintaining intraoperative blood pressure maintaining blood pressure of elderly patients during hip surgery
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Cairo, 11562, Egypt
Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg in the mean arterial pressure.
Inferior vena cava collapsibility will be used to assess the patient's intravascular volume status.
After induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization All drug preparations will be done by a research assistant who will be responsible for opening the envelope and group assignment with no further involvement in the study.
Any episode of hypotension (defined as mean arterial pressure (MAP) < 70% of the baseline or MAP<65mmHg) will be managed by 5 mcg norepinephrine.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 9 mg ephedrine. If bradycardia occurred with hypertension (MAP increase 20% over the baseline) and persisted for more than one reading, the vasopressor infusion will be stopped.
If hypertension occurred (defined as increased mean arterial pressure by > 20% of the baseline reading), vasopressor infusion will be decreased by 50%. If hypertension persisted 2 minutes after reduction of the infusion, the vasopressor infusion will be stopped. The vasopressor will be returned to 50% of the starting dose if there was further decline in blood pressure.
The infusion will continue for 45 minutes after spinal anesthesia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients will receive norepinephrine infusion at a rate 1 mL/kg/hour of 6 mcg/mL solution.
The patients will receive NE infusion at a rate 1 mL/kg/hour of 4.2 mcg/mL solution.
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
average mean arterial pressure
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
defined as mean MAP < 70% of the baseline or MAP<65mmHg
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
defined as mean MAP > 120% of the baseline
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
defined as heart rate <50 bpm
Kasr El Aini Hospital
Other
Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly Patients Undergoing Hip Surgery: A Randomized Controlled Non-inferiority Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07581561
Regional Anaesthesia, Spinal Aneshtesia
Izmir, Turkey (Türkiye)
View Trial DetailsNCT06921473
Acid-Base Imbalance, Acidosis
Diyarbakır, Turkey (Türkiye)
View Trial DetailsNCT07144215
Knee Surgery, Pelvic Surgery
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
View Trial DetailsNCT06984315
General Anesthetic, Inflammation
Tokat Province, Turkey (Türkiye)
View Trial Details