Diabetes MellitusNCT04259112
Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients
A study testing high pressure, deep neuromuscular block and low pressure in people with Diabetes Mellitus and Acute Kidney Injury, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Acute Kidney Injury, Laparoscopic Surgical Procedure
- What is being tested?
- high pressure, deep neuromuscular block and low pressure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- Severe diabetic neuropathy or other peripheral neuropathy；
- Known or suspect allergy to general anesthetics；
- Family history of malignant hyperthermia；
- Previous history of pelvic surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery
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.
Read the detailed description
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
- Diabetes Mellitus, Acute Kidney Injury, Laparoscopic Surgical Procedure, Neuromuscular Blockade
- Being tested
- high pressure, deep neuromuscular block, low pressure, moderate neuromuscular block
- Medical subject headings
- Diabetes Mellitus, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high pressureProcedure or surgery
High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.
deep neuromuscular blockDrug
Deep neuromuscular block is defined as PTC 1-2.
low pressureProcedure or surgery
Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.
moderate neuromuscular blockDrug
Moderate neuromuscular block is defined as TOF twitch 1-2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: high pressure; Drug: 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. Receives: Procedure: high pressure; Drug: 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. Receives: Drug: deep neuromuscular block; Procedure: 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. Receives: Drug: deep neuromuscular block; Drug: moderate neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cystatin C (CysC) level
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
Measured: 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).
Measured: 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).
Measured: Postoperative 24 hours
Secondary outcomes (9)
Serum creatine level
Creatine is also an indicator for kidney injury
Measured: 30 minutes before pneumoperitoneum insufflation
Serum creatine level
Creatine is also an indicator for kidney injury
Measured: 30 minutes after pneumoperitoneum deflatation
Serum creatine level
Creatine is also an indicator for kidney injury
Measured: Postoperative 24 hours
The volume of intraoperative urine output
A urine tube will be inserted just before the surgery, so the urine can be drained into a bag. The volume of urine in the bag at the end of the surgery will be the volume of intraoperative urine output.
Measured: At the end of the surgery
The presence of isomorphic or dysmorphic erythrocyte in urinary sediment
Erythrocyte in urinary sediment is also an indicator of renal injury.
Measured: Postoperative day 1
Duration of surgery
Duration of surgery is an indicator for procedure difficulty
Measured: Intraoperative
Leiden-surgical rating scale
We will use Leiden surgical rating scale (Martini et al.) to assess surgical condition. It is a 5-point scale, the minimum and maximum values are 1 and 5, respectively. Higher score indicates better surgical condition.
Measured: The moment when trocars are introduced into pelvic cavity, and then every 15 minutes till the end of surgery.
The number of bucking and body movement during the surgery
The occurrence of bucking or body movement is an indicator for the sufficiency of muscle relaxant.
Measured: Intraoperative
Renal tissue oxygen saturation
Renal oxygen saturation is an indicator for renal tissue oxygenation.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang YuGuang, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259112
- Sponsor's protocol ID
- PUMCH-ml
- Status last verified
- Oct 2020
- First submitted
- 2 Feb 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32600358
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery
- ClinicalTrials.gov ID
- NCT04259112
- Acronym / sponsor ID
- PUMCH-ml
- Conditions
- Diabetes Mellitus, Acute Kidney Injury, Laparoscopic Surgical Procedure, Neuromuscular Blockade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high pressure + deep block | Experimental | Procedure: high pressure, Drug: deep neuromuscular blockIntra-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. |
| high pressure + moderate block | Experimental | Procedure: high pressure, Drug: moderate neuromuscular blockIntra-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. |
| low pressure + deep block | Experimental | Drug: deep neuromuscular block, Procedure: low pressureIntra-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. |
| low pressure + moderate block | Experimental | Drug: deep neuromuscular block, Drug: moderate neuromuscular blockIntra-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high pressureHigh-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg. | Procedure or surgery | high pressure + deep block, high pressure + moderate block |
| deep neuromuscular blockDeep neuromuscular block is defined as PTC 1-2. | Drug | high pressure + deep block, low pressure + deep block, low pressure + moderate block |
| low pressureLow-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg. | Procedure or surgery | low pressure + deep block |
| moderate neuromuscular blockModerate neuromuscular block is defined as TOF twitch 1-2. | Drug | high pressure + moderate block, low pressure + moderate block |
Primary outcome
Serum cystatin C (CysC) level
Time frame: 30 minutes before pneumoperitoneum insufflation
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
Serum cystatin C (CysC) level
Time frame: 30 minutes after pneumoperitoneum deflatation
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
Serum cystatin C (CysC) level
Time frame: Postoperative 24 hours
CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).
9 secondary outcomes
Serum creatine level
Time frame: 30 minutes before pneumoperitoneum insufflation
Serum creatine level
Time frame: 30 minutes after pneumoperitoneum deflatation
Serum creatine level
Time frame: Postoperative 24 hours
The volume of intraoperative urine output
Time frame: At the end of the surgery
The presence of isomorphic or dysmorphic erythrocyte in urinary sediment
Time frame: Postoperative day 1
Duration of surgery
Time frame: Intraoperative
Leiden-surgical rating scale
Time frame: The moment when trocars are introduced into pelvic cavity, and then every 15 minutes till the end of surgery.
The number of bucking and body movement during the surgery
Time frame: Intraoperative
Renal tissue oxygen saturation
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 32600358Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuguang Huang, M.D. principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing high pressure, deep neuromuscular block and low pressure in people with Diabetes Mellitus and Acute Kidney Injury, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahong Gong, M.D. (86-13611273163, yh2087@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cystatin C (CysC) level (time frame: 30 minutes before pneumoperitoneum insufflation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.