Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients

January 22, 2024 updated by: The First Hospital of Qinhuangdao
To observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to the random number table method, one hundred and twenty patients who underwent elective laparoscopic colorectal surgery were divided into four groups (n=30): Normal weight patients according to lean body weight group(NL group), normal weight patients according to real weight group (NR group), obese patients according to lean body weight group(OL group), and obese patients according to real weight group(OR group).Intraoperative deep neuromuscular blockade (PTC≤2)was maintained in all four groups.The dosage of cisatracurium, the number of injections,time to effect,time to recovery from TOFr,time to recover TOFr（train-of-four rate） to 0.7 and 0.9,and time to stay in PCAU were recorded.The surgeon's satisfaction with the operative field and the average intraoperative pneumoperitoneum pressure were recorded at the time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum establishment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Qinhuangdao, China
        • The First hosptial of Qinhuangdao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Laparoscopic Colorectal Surgery
  • American Society of Anesthesiologists (ASA) grades I-III

Exclusion Criteria:

  • Patients with heart, lung and other vital organ disorders
  • Preoperative fluid and electrolyte disturbance
  • Preoperative water and electrolyte disorders have a history of neuromuscular disease or take medications that have an impact on neuromuscular function
  • There is a significant airway difficulty
  • Refuse to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Normal Real group
the medication group was given according to the actual weight of normal weight patients
Behavioral: base on Actual Body Weight
PTC was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on actual body weight once when PTC > 2.
Other Names:
  • base on Actual Body Mass Pattern
Genetic: normal patients
normal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ.
Other Names:
  • laparoscopic colorectal surgery
Active Comparator: Normal Lean group
For normal weight patients, the medication group was given according to the lean body mass
Genetic: normal patients
normal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ.
Other Names:
  • laparoscopic colorectal surgery
Behavioral: base on Lean Body Mass Pattern
PTC(post-tetanic count) was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on lean body weight mass pattern once when PTC > 2.
Other Names:
  • general anesthesia
Sham Comparator: Obese Real group
the medication group was given according to the actual weight of obese weight patients
Behavioral: base on Actual Body Weight
PTC was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on actual body weight once when PTC > 2.
Other Names:
  • base on Actual Body Mass Pattern
Genetic: obese patients
obese patients with elective laparoscopic colorectal surgery were selected，and the inclusion criteria were as follows: age 18-65, body mass index (BMI) 30-35, waist circumference (WC) : female ≥80cm, male ≥90cm, and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ.
Other Names:
  • laparoscopic colorectal surgery
Experimental: Obese Lean group
the medication group was given according to the lean body mass of obese weight patients
Behavioral: base on Lean Body Mass Pattern
PTC(post-tetanic count) was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on lean body weight mass pattern once when PTC > 2.
Other Names:
  • general anesthesia
Genetic: obese patients
obese patients with elective laparoscopic colorectal surgery were selected，and the inclusion criteria were as follows: age 18-65, body mass index (BMI) 30-35, waist circumference (WC) : female ≥80cm, male ≥90cm, and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ.
Other Names:
  • laparoscopic colorectal surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average dosing interval time
Time Frame: during the surgery
PTC(post-tetanic count)was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,average dosing interval time was recorded
during the surgery
Change in Times of adding cisatracurium
Time Frame: during the surgery
PTC was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,and recording the total times of injection.
during the surgery
Change in total dosage of cisatracurium
Time Frame: during the surgery
PTC(post-tetanic count) was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,and recording the total dosage of total dosage of cisatracurium
during the surgery
Change in time of onset
Time Frame: through study completion, an average of 3 minute after induction
0.15mg/kg (3ED95) cisatracurium was given to all groups according to actual body weight as induction dose. Tracheal intubation was performed in all groups when TOFr(train of four ratio)=0.recording the time during this process.
through study completion, an average of 3 minute after induction
Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection
Time Frame: up to 1 hour after the surgery
The recovery of TOF(train of four) was continue observed after surgery.Recording the time both when TOF(train of four) recovered to 0.7 and 0.9
up to 1 hour after the surgery
Change in time during PACU(postanesthesia care unit)
Time Frame: up to 2 hour after the surgery
recoding the duration of stay in PACU(postanesthesia care unit)
up to 2 hour after the surgery
surgical rating scale(SRS)
Time Frame: during the surgery
Surgical rating Scale (SRS) was evaluated by surgical surgeons at the beginning, 1h and 2h of surgery, with a range of 1 to 5, corresponding to "extremely poor", "poor", "adequate", "good" and "best".
during the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of MAP (mean arterial pressure)
Time Frame: immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
Mean arterial pressure were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection
immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
The change of HR(heart rate)
Time Frame: immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
the heart rate were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection
immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
Change in PaCO2 before and after pneumoperitoneum
Time Frame: before and after pneumoperitoneum during the surgery
arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum
before and after pneumoperitoneum during the surgery
Incidence of postoperative pain
Time Frame: Immediately after surgery and One day after surgery
Incidence of postoperative pain (shoulder, lumbar abdomen, arm)
Immediately after surgery and One day after surgery
Whether hypoxemia occurs after extubation
Time Frame: within 10 minutes after extubation
Observe the occurrence of hypoxemia after extubation
within 10 minutes after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Qinhuangdao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: PI qinshuang liu, master, The First hosptial of Qinhuangdao
  • Study Chair: yuli guo, master, The First hosptial of Qinhuangdao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 070733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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