Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery

NCT ID: NCT04076709

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-03-27

Brief Summary

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Many surgical procedures are performed using the laparoscopic approach. However, insufflation of the abdomen (pneumoperitoneum) has detrimental hemodynamic effects. The investigators intend to investigate the effect of deep neuromuscular block and nociception guided anaesthesia on hemodynamic variables during pneumoperitoneum for lower abdominal laparoscopic surgery.

Detailed Description

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Conditions

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Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Goal directed anesthesia

Deep neuromuscular blockade (post tetanic count 1-2 twitches) and nociception guided anaesthesia

Group Type EXPERIMENTAL

goal directed anaesthesia

Intervention Type PROCEDURE

Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25

Interventions

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goal directed anaesthesia

Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

ASA 1-3;

* Scheduled for lower laparoscopic abdominal surgery;
* Ability to give oral and written consent;

Exclusion Criteria

* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Women who are or may be pregnant;
* Preexisting cardiac disease (any);
* Untreated or uncontrolled hypertension;
* COPD gold 3 or higher
* Preexistent esophageal pathology (stricture, tumor, diverticulum)
* Any increased risk factor for upper gastro intestinal tract bleed:
* History of GI surgery;
* History of GI bleed;
* Esophageal varices;
* Gastric or esophageal inflammation;
* Severe thrombocytopenia (less than 50k) or severely elevated INR (\>4).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Martijn Boon

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P19.042

Identifier Type: -

Identifier Source: org_study_id

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