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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection under general anesthesia. 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. Neuromuscular block will be induced by rocuronium bolus and maintained by a continuous infusion of rocuronium. Deep neuromuscular block is defined as PTC 1-2, and low neuromuscular block is defined as train-of-four TOF twitch 1-2. The primary outcome will be serum Cystatin C level, and the secondary outcomes will be serum creatine level, urinary sediment, intraoperative urine output, duration of surgery, surgical space condition and occurrence bucking and body movement.

Conditions

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Diabetes Mellitus Acute Kidney Injury Laparoscopic Surgical Procedure Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The patients, surgeons and the ones who collect data will be masked.

Study Groups

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high pressure + deep block

Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards post-tetanic count (PTC) 1-2.

Group Type EXPERIMENTAL

high pressure

Intervention Type PROCEDURE

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

deep neuromuscular block

Intervention Type DRUG

Deep neuromuscular block is defined as PTC 1-2.

high pressure + moderate block

Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards train-of-four (TOF) twitch 1-2.

Group Type EXPERIMENTAL

high pressure

Intervention Type PROCEDURE

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

moderate neuromuscular block

Intervention Type DRUG

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

low pressure + deep block

Intra-abdominal pressure will be set to 7-10 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards PTC 1-2.

Group Type EXPERIMENTAL

deep neuromuscular block

Intervention Type DRUG

Deep neuromuscular block is defined as PTC 1-2.

low pressure

Intervention Type PROCEDURE

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

low pressure + moderate block

Intra-abdominal pressure will be set to 7-10 mmHg. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards TOF twitch 1-2.

Group Type EXPERIMENTAL

deep neuromuscular block

Intervention Type DRUG

Deep neuromuscular block is defined as PTC 1-2.

moderate neuromuscular block

Intervention Type DRUG

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

Interventions

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high pressure

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

Intervention Type PROCEDURE

deep neuromuscular block

Deep neuromuscular block is defined as PTC 1-2.

Intervention Type DRUG

low pressure

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

Intervention Type PROCEDURE

moderate neuromuscular block

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-70;
2. American Society of Anesthesiologist physical status (ASA) II-Ⅲ;
3. Diagnosed of diabetes;
4. Undergoing elective laparoscopic pelvic tumor resection under general anesthesia;
5. Estimated duration of operation \>2h;

Exclusion Criteria

1. Not willing to participate in the study or not able to sign the informed consent；
2. Diagnosed of other kidney diseases except diabetic nephropathy;
3. Severe renal insufficiency defined as serum creatine level \> 2 times the upper limit of normal, or urine output \< 0.5ml/kg/h, or estimated glomerular filtration rate \< 60ml/h;
4. Severe liver, lung or heart dysfunction;
5. Known or suspect neuromuscular disease;
6. Use of drugs that may affect neuromuscular block monitoring;
7. Severe diabetic neuropathy or other peripheral neuropathy；
8. Known or suspect allergy to general anesthetics；
9. Family history of malignant hyperthermia；
10. Previous history of pelvic surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No