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

October 8, 2023 updated by: Beijing Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
an average of 5 minutes，at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Collaborators

Beijing Tiantan Hospital

Investigators

  • Study Chair: Haijun Hou, MD, Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2022

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lumen208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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