This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete.
This is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.
Age 50-65 years, weight 40-65kg, male or female;
Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;
American Society of Anesthesia (ASA) grades I-II;
Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -
Patients with simple and painless gastroscopy
Allergy to this study drug and any ingredients;
Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;
Acute upper respiratory tract infection and asthma attacks;
Parallel
fospropofol Disodium for injection
DrugGroup L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)
Propofol
DrugGroup B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)
Sedation success rate
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1(The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome.) or EEG bispectral index (BIS) value \<64( The rating scale ranges from levels 0 to 100, and lower BIS score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )within 5 minutes (no additional drug within 5 minutes)
Length of successful induction of anesthesia
Time from the first start of administration of study drug to Modified Observer's Assessment of Alertness/Sedation score ≤1 ((The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome.) or EEG bispectral index (BIS) value \<64(The rating scale ranges from levels 0 to 100, and lower BIS score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
hypoxaemia
Oxygen saturation below 90% over 30 seconds or requires any type of airway assistance (including jaw support, artificial airway)
Hemodynamic index
The occurrence of hypotension, hypertension, bradycardia, and tachycardia
Limb movements of the patient during the operation
No movement of limbs (10 points); slight movement, occasionally (8 points); slight movement, frequent (6 points), vigorous movement, arms and legs only (4 points); vigorous body and head movement (2 points)
Wake up time
Time from the end of surgery until Modified Observer's Assessment of Alertness/Sedation score=5 points(The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome).
Awakening quality of anesthesia
Wake quality was assessed using a modified AIdrete score(The rating scale ranges from levels 0 to 10, and the lower the score indicates that the worse the recovery mass, namely a higher scores mean a better outcome).
General data of the patient(1)
age
General data of the patient(2)
height
General data of the patient(3)
weight
General data of the patient(4)
Other general data, including gender, current medical history, history of combined diseases and medication allergy, history of hypertension / diabetes (most hypertension / blood glucose, type and age of medication, and presence of other organs); mouth opening, the history of snoring, history of Obstructive sleep apnea and hypopnea syndrome, number of shots of gastrointestinal endoscopy, basic blood oxygen value
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Affiliated Hospital of Nantong University
Lead sponsor
Rugao People's Hospital
Collaborator
Qidong People's Hospital
Collaborator
Hai 'an People's Hospital
Collaborator
Rudong County Hospital of Traditional Chinese Medicine
Collaborator
