NCT04259112

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
648

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable diabetes-mellitus

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

February 2, 2020

Last Update Submit

October 3, 2020

Conditions

Diabetes MellitusAcute Kidney InjuryLaparoscopic Surgical ProcedureNeuromuscular Blockade

Outcome Measures

Primary Outcomes (3)

  • Serum cystatin C (CysC) level

    CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).

    30 minutes before pneumoperitoneum insufflation

  • Serum cystatin C (CysC) level

    CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).

    30 minutes after pneumoperitoneum deflatation

  • Serum cystatin C (CysC) level

    CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).

    Postoperative 24 hours

Secondary Outcomes (9)

  • Serum creatine level

    30 minutes before pneumoperitoneum insufflation

  • Serum creatine level

    30 minutes after pneumoperitoneum deflatation

  • Serum creatine level

    Postoperative 24 hours

  • The volume of intraoperative urine output

    At the end of the surgery

  • The presence of isomorphic or dysmorphic erythrocyte in urinary sediment

    Postoperative day 1

  • +4 more secondary outcomes

Study Arms (4)

high pressure + deep block

EXPERIMENTAL

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.

Procedure: high pressureDrug: deep neuromuscular block

high pressure + moderate block

EXPERIMENTAL

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.

Procedure: high pressureDrug: moderate neuromuscular block

low pressure + deep block

EXPERIMENTAL

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.

Drug: deep neuromuscular blockProcedure: low pressure

low pressure + moderate block

EXPERIMENTAL

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.

Drug: deep neuromuscular blockDrug: moderate neuromuscular block

Interventions

high pressurePROCEDURE

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

high pressure + deep blockhigh pressure + moderate block
deep neuromuscular blockDRUG

Deep neuromuscular block is defined as PTC 1-2.

high pressure + deep blocklow pressure + deep blocklow pressure + moderate block
low pressurePROCEDURE

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

low pressure + deep block
moderate neuromuscular blockDRUG

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

high pressure + moderate blocklow pressure + moderate block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not willing to participate in the study or not able to sign the informed consent；
  • Diagnosed of other kidney diseases except diabetic nephropathy;
  • 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;
  • Severe liver, lung or heart dysfunction;
  • Known or suspect neuromuscular disease;
  • Use of drugs that may affect neuromuscular block monitoring;
  • Severe diabetic neuropathy or other peripheral neuropathy；
  • Known or suspect allergy to general anesthetics；
  • Family history of malignant hyperthermia；
  • Previous history of pelvic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Xu X, Gong Y, Zhang Y, Lang J, Huang Y. Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 x 2 factorial randomized controlled trial. Trials. 2020 Jun 29;21(1):585. doi: 10.1186/s13063-020-04477-x.

    PMID: 32600358DERIVED

MeSH Terms

Conditions

Diabetes MellitusAcute Kidney Injury

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yuguang Huang, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahong Gong, M.D.

CONTACT

86-13611273163yh2087@163.com

Xiaohan Xu, M.D.

CONTACT

86-15210560817smartannie@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patients, surgeons and the ones who collect data will be masked.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of the Department of Anesthesiology

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 6, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share