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Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients

NCT04259112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2020-10-06

No results posted yet for this study

Summary

In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection. They will be randomized to the following four groups: high-pressure pneumoperitoneum (10mmHg)+ deep neuromuscular block group, high-pressure pneumoperitoneum (15mmHg)+moderate neuromuscular block group, low-pressure pneumoperitoneum + deep neuromuscular block group and low-pressure pneumoperitoneum+moderate neuromuscular block group. Deep neuromuscular block is defined as post tetanic count (PTC) 1-2, and low neuromuscular block is defined as train-of-four (TOF) twitch 1-2. The outcomes will be indicators for acute kidney injury and surgical condition.

Conditions

Interventions

PROCEDURE

high pressure

High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.

DRUG

deep neuromuscular block

Deep neuromuscular block is defined as PTC 1-2.

PROCEDURE

low pressure

Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.

DRUG

moderate neuromuscular block

Moderate neuromuscular block is defined as TOF twitch 1-2.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yuguang Huang, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-10-01
Completion
2023-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04259112 on ClinicalTrials.gov