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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Real group | Sham Comparator | the medication group was given according to the actual weight of normal weight patients |
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| Normal Lean group | Active Comparator | For normal weight patients, the medication group was given according to the lean body mass |
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| Obese Real group | Sham Comparator | the medication group was given according to the actual weight of obese weight patients |
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| Obese Lean group | Experimental | the medication group was given according to the lean body mass of obese weight patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| base on Lean Body Mass Pattern | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | 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 | 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) | up to 2 hour after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection |
| The change of HR(heart rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PI qinshuang liu, master | The First hosptial of Qinhuangdao | Study Director |
| yuli guo, master | The First hosptial of Qinhuangdao | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First hosptial of Qinhuangdao | Qinhuangdao | China |
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|
| base on Actual Body Weight | Behavioral | 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. |
|
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| obese patients | Genetic | 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. |
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| normal patients | Genetic | 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. |
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| 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". | during the surgery |
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 | 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 | Incidence of postoperative pain (shoulder, lumbar abdomen, arm) | Immediately after surgery and One day after surgery |
| Whether hypoxemia occurs after extubation | Observe the occurrence of hypoxemia after extubation | within 10 minutes after extubation |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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