AnesthesiaNCT05497492
Comparison of the Effects of Esketamine, Sufentanil, or Lidocaine on Tussis Reflection During Upper Gastroscopy
A study testing propofol, propofol and sufentanil and propofol and esketamine in people with Anesthesia, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- propofol, propofol and sufentanil and propofol and esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Haijun Hou, +8618612568228, 77790690@qq.com
About this study
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
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.
Read the 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
- Conditions
- Anesthesia
- Being tested
- propofol, propofol and sufentanil, propofol and esketamine, propofol and lidocaine
- Keywords
- gastroscopy, esketamine, sufentanil, lidocaine, propofol, tussis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called P
single administration of propofol
propofol and sufentanilDrug
Also called P+S
administration of propofol and sufentanil in combination
propofol and esketamineDrug
Also called P+K
administration of propofol and esketamine in combination
propofol and lidocaineDrug
Also called P+L
administration of propofol and lidocaine in combination
| Study group | Role | What they receive |
|---|---|---|
| P group | Active comparator | single administration of propofol Receives: Drug: propofol |
| P + S group | Experimental | administration of propofol and sufentanil in combination Receives: Drug: propofol and sufentanil |
| P + K group | Experimental | administration of propofol and esketamine in combination Receives: Drug: propofol and esketamine |
| P + L group | Experimental | administration of propofol and lidocaine in combination Receives: Drug: propofol and lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: an average of 5 minutes，at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion
Secondary outcomes (5)
recovery time
recovery time from anesthesia
Measured: an average of 30 minutes，the time from withdrawal of endoscopy to obeying verbal commands
propofol dosage during operation
propofol dosage during operation
Measured: through study completion, an average of 20 minutes，the time from insertion endoscopy to withdrawal of endoscopy
incidence of perioperative adverse events
incidence of perioperative adverse events
Measured: through study completion, an average of 1 year，the time from insertion endoscopy to withdrawal of endoscopy
incidence of postoperative adverse events
incidence of postoperative adverse events
Measured: through study completion, an average of 1 year，
MMSE scores after operation
MMSE scores
Measured: through study completion, an average of 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start5 Nov 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Haijun Hou, MD, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497492
- Sponsor's protocol ID
- lumen208
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23382625Canning 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.
PubMed 20172253Wehrmann 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.
PubMed 20407257Byrne 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.
PubMed 18478130Ho 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.
PubMed 23170921Poulos 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.
PubMed 23513321Zhang 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.
PubMed 25318000Hou HJ, Liu L, Tian M, Xue FS. Comparison of the effects of esketamine, sufentanil, or lidocaine combined with propofol on tussis reflection during upper gastrointestinal endoscopy: study protocol for a randomised, two centre, three-blind, controlled trial. Trials. 2024 Jan 4;25(1):24. doi: 10.1186/s13063-023-07812-0.
PubMed 38178168
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05497492
- Acronym / sponsor ID
- lumen208
- Conditions
- Anesthesia
- Keywords
- gastroscopy, esketamine, sufentanil, lidocaine, propofol, tussis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P group | Active comparator | Drug: propofolsingle administration of propofol |
| P + S group | Experimental | Drug: propofol and sufentaniladministration of propofol and sufentanil in combination |
| P + K group | Experimental | Drug: propofol and esketamineadministration of propofol and esketamine in combination |
| P + L group | Experimental | Drug: propofol and lidocaineadministration of propofol and lidocaine in combination |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- allergic reaction to planned medication
- gravis myasthenia
- history of psychological problems or psychiatric disease
- morbid obesity/obstructive sleep apnea
- acute upper respiratory infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: Psingle administration of propofol | Drug | P group |
| propofol and sufentanilAlso: P+Sadministration of propofol and sufentanil in combination | Drug | P + S group |
| propofol and esketamineAlso: P+Kadministration of propofol and esketamine in combination | Drug | P + K group |
| propofol and lidocaineAlso: P+Ladministration of propofol and lidocaine in combination | Drug | P + L group |
Primary outcome
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
5 secondary outcomes
recovery time
Time frame: 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
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 postoperative adverse events
Time frame: through study completion, an average of 1 year，
MMSE scores after operation
Time frame: through study completion, an average of 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Results publication: PubMed 23382625Triantafillidis 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.
- Results publication: PubMed 20172253Canning 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.
- Results publication: PubMed 20407257Wehrmann 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.
- Results publication: PubMed 18478130Byrne 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.
- Results publication: PubMed 23170921Ho 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.
- Results publication: PubMed 23513321Poulos 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.
- Results publication: PubMed 25318000Zhang 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.
- Derived from this study: PubMed 38178168Hou HJ, Liu L, Tian M, Xue FS. Comparison of the effects of esketamine, sufentanil, or lidocaine combined with propofol on tussis reflection during upper gastrointestinal endoscopy: study protocol for a randomised, two centre, three-blind, controlled trial. Trials. 2024 Jan 4;25(1):24. doi: 10.1186/s13063-023-07812-0.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haijun Hou, MD study chair
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, propofol and sufentanil and propofol and esketamine in people with Anesthesia, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haijun Hou, MD (+8618612568228, lumen208@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: an average of 5 minutes，at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497492, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.