Clinical trial NCT05497492: Comparison of the Effects of Esketamine, Sufentanil, or Lidocaine on Tussis Reflection During Upper Gastroscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: gastroscopy
esketamine
sufentanil
lidocaine
propofol
tussis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2022-08-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The patients are selected according to their inclusion and exclusion criteria for diagnostic upper GI endoscopy and informed consent. The patients will be divided into the four groups: P group (single administration of propofol), P + S group (administration of propofol and sufentanil in combination), P + K group (administration of propofol and esketamine in combination), and P + L group (administration of propofol and lidocaine in combination) (N = 100 per group). Baseline information will be collected and recorded before the operation. Anaesthetic drugs will be prepared by the nurses and anaesthetists on the day of the operation as follows: 0.9% normal saline (20 mL) for the P group, 0.5 μg/mL sufentanil (20 mL) for the P + S group, 1.5 mg/mL esketamine (20 mL) for the P + K group, and 10 mg/mL lidocaine (20 mL) for the P + L group. Before entering the operating room, the patients will be given lidocaine defoamer for gargling to open the upper limb vein and 5 mL/min Lactate Ringer solution. After entering the room, the patients will wear masks to inhale high-flow oxygen, and their vital signs will be monitored and recorded as Tire. Analgesic drugs (diluted to 20 mL according to different concentrations) prepared by the nurses will be slowly injected into their veins 5 min before examination for 30 s (the dose was calculated using the formula: the injected drug dose (ml) = the weight of the patient (kg)/10"; 1.5 mg/kg propofol will be intravenously administrated. . Multiple-dose administration is acceptable according to the state of the patient. The endoscope will be inserted when the eyelash reflex disappeared (sedation depth grade: deep sedation). Blood pressure will be recorded after every 3 min from the beginning of the examination, and HR, SpO2, and RR will be recorded simultaneously. The frequency and degree of tussis, nausea, and vomiting and/or body movements at endoscope insertion or within 5 min of insertion will be monitored. In case of any abnormalities, they should be described in detail, and appropriate doses of propofol should be added until the endoscope exits the teeth pad. During endoscopy, 2-4 mL of propofol should be added under the conditions of extended operation time, accelerated breathing, and elevated blood pressure and heart rate to maintain deep sedation. The patients will be transferred to a recovery room after the operation, and their vital signs will be recorded after every 5 min until the patients met the standard of leaving the hospital (Steward score ≥ 4) before discharge

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.

Primary outcomes:
measure: 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.
timeFrame: an average of 5 minutes，at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion
Secondary outcomes:
measure: recovery time
timeFrame: an average of 30 minutes，the time from withdrawal of endoscopy to obeying verbal commands
measure: propofol dosage during operation
timeFrame: through study completion, an average of 20 minutes，the time from insertion endoscopy to withdrawal of endoscopy
measure: incidence of perioperative adverse events
timeFrame: through study completion, an average of 1 year，the time from insertion endoscopy to withdrawal of endoscopy
measure: incidence of postoperative adverse events
timeFrame: through study completion, an average of 1 year，
measure: MMSE scores after operation
timeFrame: through study completion, an average of 1 year after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Haijun Hou, MD
role: STUDY_CHAIR
References:
citation: Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.
citation: Canning BJ. Afferent nerves regulating the cough reflex: mechanisms and mediators of cough in disease. Otolaryngol Clin North Am. 2010 Feb;43(1):15-25, vii. doi: 10.1016/j.otc.2009.11.012.
citation: Wehrmann T, Triantafyllou K. Propofol sedation in gastrointestinal endoscopy: a gastroenterologist's perspective. Digestion. 2010;82(2):106-9. doi: 10.1159/000285554. Epub 2010 Apr 21.
citation: Byrne MF, Chiba N, Singh H, Sadowski DC; Clinical Affairs Committee of the Canadian Association of Gastroenterology. Propofol use for sedation during endoscopy in adults: a Canadian Association of Gastroenterology position statement. Can J Gastroenterol. 2008 May;22(5):457-9. doi: 10.1155/2008/268320.
citation: Ho WM, Yen CM, Lan CH, Lin CY, Yong SB, Hwang KL, Chou MC. Comparison between the recovery time of alfentanil and fentanyl in balanced propofol sedation for gastrointestinal and colonoscopy: a prospective, randomized study. BMC Gastroenterol. 2012 Nov 21;12:164. doi: 10.1186/1471-230X-12-164.
citation: Poulos JE, Kalogerinis PT, Caudle JN. Propofol compared with combination propofol or midazolam/fentanyl for endoscopy in a community setting. AANA J. 2013 Feb;81(1):31-6.
citation: Zhang L, Bao Y, Shi D. Comparing the pain of propofol via different combinations of fentanyl, sufentanil or remifentanil in gastrointestinal endoscopy. Acta Cir Bras. 2014 Oct;29(10):675-80. doi: 10.1590/s0102-8650201400160008.