Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517524
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Low-pressure Pneumoperitoneum Associated With Deep Pipecuronium-induced Neuromuscular Blockade on Hemodynamic Parameters for High Cardiovascular Risk Patient Undergoing General Anesthesia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Deep neuromuscular block DNMB during laparoscopy induces less haemodynamic stress by facilitating low-pressure pneumoperitoneum the investigators tested the feasibility of pipecuronium-induced deep post-tetanic count 1 train-of-four count 0 NMB to allow low intraabdominal pressures and maintain cardiovascular stability in patients with low cardiac ejection fractionMethodsTen adult NYHA 3-4 surgical patients requiring non-elective abdominal surgery were included Pipecuronium bromide PIPE 009 mgkg was used for muscle relaxation and maintenance of DNMB Top-up doses of PIPE were administered when the post-tetanic count was 4-8
Intraabdominal pressures IAP were kept below 10 mmHg Mean arterial pressure MAP was measured intra-arterially Outcome measures used weight in kilograms height in meters need for circulatory suppert yesno success of maintenance yesno Surgical field view was rated on a 5-point scale 1 extremely poor 5 optimal
Intraabdominal pressures IAP were kept below 10 mmHg Mean arterial pressure MAP was measured intra-arterially Outcome measures used weight in kilograms height in meters need for circulatory suppert yesno success of maintenance yesno Surgical field view was rated on a 5-point scale 1 extremely poor 5 optimal
Detailed Description:
Patients with a high cardiovascular risk who undergo lparoscopic cholecystectomy before cardiac surgery were included in the study It is known from the literature that low pressure pneumoperitoneum has less circulatory effects than normal pressure pneumoperitoneumThe abdominal muscles are well relaxed by a deep neuromuscular block using a pypecuronium bromide muscle relaxant The quality of the surgical field of view is expected to improve With deep muscle relaxation low-pressure pneumoperitoneum can be easily maintained thus the investigators hypothesise that patients will remain haemodynamically stable during surgery
Primary endpoint of the study
Maintenance of low-pressure 6-10 mmHg pneumoperitoneum during surgery using deep NMB with pipecuronium as neuromuscular blocking agent
Secondary endpoint of the study
Number of cases with successful reversal of deep neuromuscular block to TOFR 09 within 3 min after administration of 2 mgkg sugammadex
Additional endpoints
Changes in hemodynamic parameters during surgery need for pharmacologic circulatory support Quality of the surgical field of view rated by the surgeon
Primary endpoint of the study
Maintenance of low-pressure 6-10 mmHg pneumoperitoneum during surgery using deep NMB with pipecuronium as neuromuscular blocking agent
Secondary endpoint of the study
Number of cases with successful reversal of deep neuromuscular block to TOFR 09 within 3 min after administration of 2 mgkg sugammadex
Additional endpoints
Changes in hemodynamic parameters during surgery need for pharmacologic circulatory support Quality of the surgical field of view rated by the surgeon
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None