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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05497492

Collaborator

Beijing Tiantan Hospital (Other)

400

Enrollment

Arms

5.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: propofol Drug: propofol and sufentanil Drug: propofol and esketamine Drug: propofol and lidocaine	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: P group single administration of propofol	Drug: propofol single administration of propofol Other Names: P
Experimental: P + S group administration of propofol and sufentanil in combination	Drug: propofol and sufentanil administration of propofol and sufentanil in combination Other Names: P+S
Experimental: P + K group administration of propofol and esketamine in combination	Drug: propofol and esketamine administration of propofol and esketamine in combination Other Names: P+K
Experimental: P + L group administration of propofol and lidocaine in combination	Drug: propofol and lidocaine administration of propofol and lidocaine in combination Other Names: P+L

Outcome Measures

Primary Outcome Measures

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]
the frequency of tussis

Secondary Outcome Measures

recovery time [an average of 30 minutes，the time from withdrawal of endoscopy to obeying verbal commands]
recovery time from anesthesia
propofol dosage during operation [through study completion, an average of 20 minutes，the time from insertion endoscopy to withdrawal of endoscopy]
propofol dosage during operation
incidence of perioperative adverse events [through study completion, an average of 1 year，the time from insertion endoscopy to withdrawal of endoscopy]
incidence of perioperative adverse events
incidence of postoperative adverse events [through study completion, an average of 1 year，]
incidence of postoperative adverse events
MMSE scores after operation [through study completion, an average of 1 year after operation]
MMSE scores