An interventional study of base on Lean Body Mass Pattern and base on Actual Body Weight in Obese Patients and Laparoscopic Colorectal Surgery, sponsored by The First Hospital of Qinhuangdao. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by The First Hospital of Qinhuangdao · Not applicable, Interventional, and Treatment
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
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →The First Hospital of Qinhuangdao is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the medication group was given according to the actual weight of normal weight patients
Behavioral: base on Actual Body Weight · Genetic: normal patients
For normal weight patients, the medication group was given according to the lean body mass
Behavioral: base on Lean Body Mass Pattern · Genetic: normal patients
the medication group was given according to the actual weight of obese weight patients
Behavioral: base on Actual Body Weight · Genetic: obese patients
the medication group was given according to the lean body mass of obese weight patients
Behavioral: base on Lean Body Mass Pattern · Genetic: obese patients
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.
Also known as: general anesthesia
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.
Also known as: base on Actual Body Mass Pattern
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.
Also known as: 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.
Also known as: laparoscopic colorectal surgery
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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".
Time frame: during the surgery
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
Time frame: 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
Time frame: 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
Time frame: before and after pneumoperitoneum during the surgery
Incidence of postoperative pain
Incidence of postoperative pain (shoulder, lumbar abdomen, arm)
Time frame: Immediately after surgery and One day after surgery
Whether hypoxemia occurs after extubation
Observe the occurrence of hypoxemia after extubation
Time frame: within 10 minutes after extubation
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Jun 2022, 15 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 15 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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The First Hospital of Qinhuangdao