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Clinical trial

Comparison of the Effects of Esketamine, Sufentanil, or Lidocaine Combined With Propofol on Tussis Reflection During Upper Gastroscopy: a Randomised, Two Centre, Three-blind, Controlled Trial

ID
Name
lumen208
Description
the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 min of endoscope insertion.
Trial arms
Trial start
2022-11-05
Estimated PCD
2023-12-30
Trial end
2023-12-30
Status
Recruiting
Treatment
propofol
single administration of propofol
Arms:
P group
Other names:
P
propofol and sufentanil
administration of propofol and sufentanil in combination
Arms:
P + S group
Other names:
P+S
propofol and esketamine
administration of propofol and esketamine in combination
Arms:
P + K group
Other names:
P+K
propofol and lidocaine
administration of propofol and lidocaine in combination
Arms:
P + L group
Other names:
P+L
Size
400
Primary endpoint
the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion.
an average of 5 minutes，at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion
Eligibility criteria
Inclusion Criteria * undergoing diagnostic upper GI endoscopy under deep propofol sedation * \>18 year old * meeting the classification I-III of American Society of Anesthesiologists (ASA) * getting written informed consent Exclusion Criteria: * allergic reaction to planned medication * gravis myasthenia * history of psychological problems or psychiatric disease * morbid obesity/obstructive sleep apnea * acute upper respiratory infections * asthma at acute stage * history of unregulated or malignant hypertension * history of significant ischemic heart disease or severe arrhythmia * severe liver or kidney dysfunction or coagulation disorders * acute upper GI haemorrhage with shock * severe anaemia * GI obstruction with gastric retention * seizure disorders * long-term history of sedative and analgesic drug use * increased intracranial pressure.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-10-10

1 organization

4 products

1 indication

Organization
Beijing Friendship Hospital
Product
propofol
Indication
Anesthesia
Product
Propofol + Sufentanil
Product
Propofol + Esketamine
Product
Propofol + Lidocaine