Obese PatientsNCT05391958
Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
A study testing base on Lean Body Mass Pattern, base on Actual Body Weight and obese patients in people with Obese Patients and Laparoscopic Colorectal Surgery, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese Patients, Laparoscopic Colorectal Surgery
- What is being tested?
- base on Lean Body Mass Pattern, base on Actual Body Weight and obese patients
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2021to 3 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laparoscopic Colorectal Surgery
- American Society of Anesthesiologists (ASA) grades I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Obese Patients, Laparoscopic Colorectal Surgery
- Being tested
- base on Lean Body Mass Pattern, base on Actual Body Weight, obese patients, normal patients
- Keywords
- Laparoscopy, Cisatracurium, Obesity, Neuromuscular Blockade, Pneumoperitoneum, Pharmacology
- Medical subject headings
- Obesity, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
base on Lean Body Mass PatternBehavioural
Also called general anesthesia
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.
base on Actual Body WeightBehavioural
Also called base on Actual Body Mass Pattern
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.
obese patientsGenetic
Also called laparoscopic colorectal surgery
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.
normal patientsGenetic
Also called laparoscopic colorectal surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Real group | Sham comparator | the medication group was given according to the actual weight of normal weight patients Receives: Behavioral: base on Actual Body Weight; Genetic: normal patients |
| Normal Lean group | Active comparator | For normal weight patients, the medication group was given according to the lean body mass Receives: Behavioral: base on Lean Body Mass Pattern; Genetic: normal patients |
| Obese Real group | Sham comparator | the medication group was given according to the actual weight of obese weight patients Receives: Behavioral: base on Actual Body Weight; Genetic: obese patients |
| Obese Lean group | Experimental | the medication group was given according to the lean body mass of obese weight patients Receives: Behavioral: base on Lean Body Mass Pattern; Genetic: obese patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average dosing interval time
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
Measured: during the surgery
Change in Times of adding cisatracurium
PTC was measured every 6min during the operation, and cisatracurium was injected once when PTC > 2,and recording the total times of injection.
Measured: during the surgery
Change in total dosage of cisatracurium
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
Measured: during the surgery
Change in time of onset
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.
Measured: 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
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
Measured: up to 1 hour after the surgery
Change in time during PACU(postanesthesia care unit)
recoding the duration of stay in PACU(postanesthesia care unit)
Measured: up to 2 hour after the surgery
surgical rating scale(SRS)
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".
Measured: during the surgery
Secondary outcomes (5)
The change of MAP (mean arterial pressure)
Mean arterial pressure were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection
Measured: immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
The change of HR(heart rate)
the heart rate were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection
Measured: immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection
Change in PaCO2 before and after pneumoperitoneum
arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum
Measured: before and after pneumoperitoneum during the surgery
Incidence of postoperative pain
Incidence of postoperative pain (shoulder, lumbar abdomen, arm)
Measured: Immediately after surgery and One day after surgery
Whether hypoxemia occurs after extubation
Observe the occurrence of hypoxemia after extubation
Measured: within 10 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start16 Mar 2021
- Primary completion30 Jun 2022
- Study completion3 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- PI qinshuang liu, master, Study director, The First hosptial of Qinhuangdaoyuli guo, master, Study chair, The First hosptial of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391958
- Sponsor's protocol ID
- 070733
- Status last verified
- Jan 2024
- First submitted
- 7 May 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
- ClinicalTrials.gov ID
- NCT05391958
- Acronym / sponsor ID
- 070733
- Conditions
- Obese Patients, Laparoscopic Colorectal Surgery
- Keywords
- Laparoscopy, Cisatracurium, Obesity, Neuromuscular Blockade, Pneumoperitoneum, Pharmacology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 26 May 2022 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Real group | Sham comparator | Behavioral: base on Actual Body Weight, Genetic: normal patientsthe medication group was given according to the actual weight of normal weight patients |
| Normal Lean group | Active comparator | Behavioral: base on Lean Body Mass Pattern, Genetic: normal patientsFor normal weight patients, the medication group was given according to the lean body mass |
| Obese Real group | Sham comparator | Behavioral: base on Actual Body Weight, Genetic: obese patientsthe medication group was given according to the actual weight of obese weight patients |
| Obese Lean group | Experimental | Behavioral: base on Lean Body Mass Pattern, Genetic: obese patientsthe medication group was given according to the lean body mass of obese weight patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Laparoscopic Colorectal Surgery
- American Society of Anesthesiologists (ASA) grades I-III
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| base on Lean Body Mass PatternAlso: general anesthesiaPTC(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. | Behavioural | Normal Lean group, Obese Lean group |
| base on Actual Body WeightAlso: base on Actual Body Mass PatternPTC 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. | Behavioural | Normal Real group, Obese Real group |
| obese patientsAlso: laparoscopic colorectal surgeryobese 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. | Genetic | Obese Lean group, Obese Real group |
| normal patientsAlso: laparoscopic colorectal surgerynormal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ. | Genetic | Normal Lean group, Normal Real group |
Primary outcome
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
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.
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
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.
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
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)
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".
5 secondary outcomes
The change of MAP (mean arterial pressure)
Time frame: 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
Change in PaCO2 before and after pneumoperitoneum
Time frame: before and after pneumoperitoneum during the surgery
Incidence of postoperative pain
Time frame: Immediately after surgery and One day after surgery
Whether hypoxemia occurs after extubation
Time frame: within 10 minutes after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- 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.
PI qinshuang liu, master study director
The First hosptial of Qinhuangdao
yuli guo, master study chair
The First hosptial of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing base on Lean Body Mass Pattern, base on Actual Body Weight and obese patients in people with Obese Patients and Laparoscopic Colorectal Surgery, run by The First Hospital of Qinhuangdao at 1 site in China.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average dosing interval time (time frame: during the surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.