Comparison of the Effects of Esketamine, Sufentanil, or Lidocaine on Tussis Reflection During Upper Gastroscopy

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497492
• Other study ID #: lumen208
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Beijing Friendship Hospital
• Contact: Haijun Hou, MD
• Phone: +8618612568228
• Email: lumen208[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• propofol
single administration of propofol
• propofol and sufentanil
administration of propofol and sufentanil in combination
• propofol and esketamine
administration of propofol and esketamine in combination
• propofol and lidocaine
administration of propofol and lidocaine in combination

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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; — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the frequency of tussis	an average of 5 minutes,at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion
Secondary	recovery time	recovery time from anesthesia	an average of 30 minutes,the time from withdrawal of endoscopy to obeying verbal commands
Secondary	propofol dosage during operation	propofol dosage during operation	through study completion, an average of 20 minutes,the time from insertion endoscopy to withdrawal of endoscopy
Secondary	incidence of perioperative adverse events	incidence of perioperative adverse events	through study completion, an average of 1 year,the time from insertion endoscopy to withdrawal of endoscopy
Secondary	incidence of postoperative adverse events	incidence of postoperative adverse events	through study completion, an average of 1 year,
Secondary	MMSE scores after operation	MMSE scores	through study completion, an average of 1 year after operation