Gastrointestinal DiseasePhase 3NCT01887184
Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy
A Phase 3 study testing Dexmedetomidine in people with Gastrointestinal Disease, run by The University of Hong Kong.
Trial summary
Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may be associated with discomfort. Although upper endoscopy is usually of shorter duration and better tolerated by patients, most trials investigating the influence of analgesia and sedation have been performed on patients… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastrointestinal Disease
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology grade I-III
- 18-60 years old
- Patients having upper endoscopy
Who cannot join
- Clinical history or electrocardiographic evidence of heart block, ischaemic - heart disease, asthma, sleep apnoea syndrome
- BMI > 35kg/m2
- Impaired liver (preoperative serum albumin level less than 30g/L ) or renal function (creatinine >120umol/L)) or known renal or hepatic disease
- Alcohol consumption in excess of 28 units per week
- Pregnancy
- Patient refusal
- Known psychiatric illness
- Chronic sedative use, and regular use of or known allergy to dexmedetomidine, propofol and opioids.
About this study
Official title: A Study to Assess Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy
Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may be associated with discomfort. Although upper endoscopy is usually of shorter duration and better tolerated by patients, most trials investigating the influence of analgesia and sedation have been performed on patients undergoing this procedure. Some patients may tolerate colonoscopy without sedation, but various techniques are used to limit discomfort and pain. Selection and dosing of sedatives depends on the patient's emotional state, the intensity of pain during examination, foreseeable technical difficulties, the endoscopist's experience, the presence or absence of anesthesia personnel, and hospital-specific procedures.
Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal endoscopy. The combination of an opioid and a benzodiazepine is known to provide good analgesic and sedative conditions during endoscopy. This combination of opioid and benzodiazepine, however, also increases the risk of respiratory depression. Therefore, pharmacologic agents which may provide adequate sedation without respiratory depression are of great interest to clinicians.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as a full agonist in most pharmacologic test models. Potentially desirable properties include decreased requirements for other anesthetics and analgesics, a diminished sympathetic response to stress and the potential for cardioprotective effects against myocardial ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its lack of respiration depression is a distinct advantage. Previous studies using dexmedetomidine for sedation has been promising with maintenance of respiratory function. Patients are readily arousable. With intravenous slow bolus administration, there is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. Many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.
Read the detailed description
Aims:
This study aims to evaluate sedative effects using intranasal dexmedetomidine in upper gastrointestinal endoscopy. The investigators aim to evaluate the efficacy, side effects and acceptability of sedation using intranasal dexmedetomidine by patients and endoscopist for upper gastrointestinal endoscopy.
Methods:
Double blind randomized prospective study.
Sample size:
We are planning to detect not less than 30% decrease of rescue propofol consumption when using intranasal dexmedetomidine. Assuming the average propofol consumption for the upper gastrointestinal endoscopy to be 40mg with SD=15mg, the required sample size with 80% power of test is 25 per group at the 0.05 level of significance.
They will be randomly allocated to one of the following study groups:
Group D: Intranasal dexmedetomidine 1.5mcg/kg; Group P: Intranasal saline (placebo)
In addition, rescue sedation will be provided by a patient-controlled sedation using propofol/ alfentanil in both groups. Patient-controlled sedation (PCS) has been shown to provide safe and effective sedation for the individual patient by allowing the patient to decide whether he or she requires sedation and to determine the amount required. PCS has been used for various procedures performed under local and regional anesthesia. PCS with propofol and alfentanil has been used for sedation of patients during endoscopy.
Process Written consent will be signed. No sedative premedication will be prescribed. The patients will be fasted for 6 hours before the procedure. Then patients will be sent to the endoscopy room about 1 hour before the procedure. A nasal catheter is positioned to deliver oxygen if oxygen is needed. Vital signs including heart rate, blood pressure, SpO2 and respiratory rate will be recorded. After obtaining baseline hemodynamic data (NIBP, HR) and respiratory data (SpO2, RR), the patients will be asked to evaluate their baseline levels of anxiety using a numerical rating scale.
The intranasal study drugs will be administrated according to a code on a piece of folded paper drawn randomly from a box. The patients will be randomly allocated to one of the two treatment groups and sedation will be performed 1 hour before the procedure as follows:
- Placebo (0.015ml/kg); D) Intranasal dexmedetomidine 0.015ml/kg
Before study drug administration, patients gently blow their noses. After baseline testing, an investigator who is blind to the study medication will administers the study drug to each naris and the patient remains in a semi-recumbent position with the head of the bed elevated at a 20-40 angle.
After which, measurements including HR, NiBP, SpO2, RR will be recorded every 5 minutes while Numerical Rating Scale of anxiety every 15 minutes. Sedation is evaluated by investigator using Observer Assessment of Alertness/ Sedation (OAA/S]) scale every 15 minutes. Both the investigators and the subjects are blinded to the study medications. The patient will be shown 2 cards of picture about 1 hour after the study drug administration.
An intravenous cannula will be inserted then. The degree of the cannulation pain will be assessed as using NRSpaincannulation. The intravenous cannula is connected to a 50 mL syringe patient-controlled analgesia pump containing 200 mg (20 mL) propofol and 0.5 mg (1 mL) alfentanil, which will be provided as the rescue sedative medications. The drugs are delivered in response to pressure on a hand-held button. Each bolus dose of 0.5 mL delivered contained 4.8 mg propofol and 12 μg alfentanil. No loading dose was used and the lock out time was set at zero. Despite the zero lock out time, a few seconds were required for the pump to deliver the preset bolus. The PCA pump was programmed to deliver a bolus dose of 0.5 ml at 200 ml/h on patient's demand and the pump took 9 s to deliver the bolus, during which time it would not respond to a further demand. Thus, the effective lockout time was 9s. Patients are instructed in the use of the hand-held button before upper endoscopy.
After the cannulation, local anesthetic spray will be administered to the oropharynx or rectum. 10 minutes after the local anesthesia, patient may start to push the button. When the first dose of propofol and alfentanil is infused, patient will be asked whether there is any pain of infusion, and the degree of the pain will be assessed as Numerical Rating Scale of pain due to infusion.
The procedure will be started once the patients feel that they are relaxed. Vital signs including NIBP, SpO2, HR, RR, and OAA/S will be monitored throughout the sedation and procedure process every 5 minutes. If the patient becomes totally unresponsive or any adverse event occurs, the procedure will be stopped. If the SpO2 falls to below 90% for more than 10 seconds, the endoscope will be removed and the patient's vital signs observed, and O2 administered as required by the attending anesthesiologist until the patient becomes responsive again. Once the patient starts responding to command, the procedure will continue. Duration of unresponsiveness would be recorded. The time of start of procedure and duration of procedure and the frequencies of interruption due to patient events will be noted. The PCS propofol and alfentanil will be terminated and disconnected from the patient when the endoscopist indicates that the operative procedure is completed, and the dose consumption recorded. The endoscopist will determine the operating conditions by evaluating the ease of insertion and the patient's lack of motion and ability to obey commands, using NRSsatisfactionendoscopist.
The patients will be transferred to the recovery room for monitoring for 30 minutes. The vital signs (blood pressure, pulse, RR and SpO2, and OAA/S) will be continued every 5 min. When the patients are fully recovered, they will be asked if there is any pain and discomfort and their severity will be assessed as NRSpain and NRSdiscomfort during the procedure. Discomfort is defined as 'a feeling of uneasiness that interfered with the patient's ability to relax'. They will also be asked if they remember any of the following events: the pictures shown to them, the insertion of the endoscope, the discomfort and pain during the examination.
Discharge criteria will be assessed as postanaesthesia discharge score hourly. When the patients are fully recovered, defined as an OAA/S score of 5 and the postanaesthesia score is more than 9, they are fit for discharge. Satisfaction evaluation of sedation will be graded by the patients on NRS in satisfaction patient. They will be questioned on whether they think that they have received an adequate amount of sedation, too little or too much, whether they are relaxed and whether they will undergo the same procedure again.
Data Collection
- Demographic data
- Type of endoscopy
- Duration of sedation
- Duration of procedure
- Duration of recovery area
- Duration from the end of procedure to become fully awake
- Duration at general ward before discharge
- Pain severity (NRS of pain) of cannulation, when being infused of propofol and alfentanil, during the examination
- Vital signs before and during the sedation, during the procedure and Postoperatively (HR, NIBP, SpO2, RR)
- OAA/S before and after administration, during and after procedure
- NRSpain and NRSdiscomfort after administration, during and after procedure
- Time when OAA/S is 4
- Tries and goods of propofol and alfentanil during the procedure
- Propofol and alfentanil consumption
- NRSsatisfactionendoscopist
- NRSsatisfactionpatient
- Adverse events and severity intraoperatively and postoperatively including oversedation, respiratory depression, hypotension, paradoxical reaction, dizziness, nausea and vomiting, bradycardia. The severity of adverse event are graded as follows:
Mild: no treatment Moderate: require treatment Severe: refractory to treatment
Data Analysis Student t test, Mann-Whitney U test and Chi-square test are applied on the analysis.
Study Duration: 18 months. Provide some data on current case load of upper endoscopies in Queen Mary Hospital.
- Conditions
- Gastrointestinal Disease
- Being tested
- Dexmedetomidine, Placebo
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine (Hospira)
Dexmedetomidine 1.5mcg/kg was given intranasally
PlaceboDrug
Intranasal saline was given
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Normal saline was given intranasally Receives: Drug: Placebo |
| Dexmedetomidine | Active comparator | 1.5mcg dexmedetomidine was given intranasally before procedure Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of Rescue Patient Controlled Propofol
Until the removal of the endoscopy from the patients
Measured: Up to 30 minutes during gastrointestinal endoscopy
Secondary outcomes (1)
Side Effects of Intrananasal Dexmedetomidine
Patients were asked the side effects up to 24 hours after upper endoscopy.
Measured: Up to 24 hours after Upper Endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chi-Wai Cheung, The University of Hong Kong
- Investigators
- Chi Wai Cheung, MBBS, MD, Principal investigator, Department of Anaesthesiology, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887184
- Sponsor's protocol ID
- UW 07-212
- Status last verified
- Jul 2024
- First submitted
- 2 Apr 2013
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT01887184
- Acronym / sponsor ID
- UW 07-212
- Conditions
- Gastrointestinal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may be associated with discomfort. Although upper endoscopy is usually of shorter duration and better tolerated by patients, most trials investigating the influence of analgesia and sedation have been performed on patients undergoing this procedure. Some patients may tolerate colonoscopy without sedation, but various techniques are used to limit discomfort and pain. Selection and dosing of sedatives depends on the patient's emotional state, the intensity of pain during examination, foreseeable technical difficulties, the endoscopist's experience, the presence or absence of anesthesia personnel, and hospital-specific procedures.
Conscious sedation is a popular technique for colonoscopy and upper gastrointestinal endoscopy. The combination of an opioid and a benzodiazepine is known to provide good analgesic and sedative conditions during endoscopy. This combination of opioid and benzodiazepine, however, also increases the risk of respiratory depression. Therefore, pharmacologic agents which may provide adequate sedation without respiratory depression are of great interest to clinicians.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative and analgesic effects. Compared with clonidine, it is more selective for the α 2 adrenoceptor and acts as a full agonist in most pharmacologic test models. Potentially desirable properties include decreased requirements for other anesthetics and analgesics, a diminished sympathetic response to stress and the potential for cardioprotective effects against myocardial ischemia. When compared with conventional sedatives such as opioids or benzodiazepines, its lack of respiration depression is a distinct advantage. Previous studies using dexmedetomidine for sedation has been promising with maintenance of respiratory function. Patients are readily arousable. With intravenous slow bolus administration, there is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. Many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.
Detailed description
Aims:
This study aims to evaluate sedative effects using intranasal dexmedetomidine in upper gastrointestinal endoscopy. The investigators aim to evaluate the efficacy, side effects and acceptability of sedation using intranasal dexmedetomidine by patients and endoscopist for upper gastrointestinal endoscopy.
Methods:
Double blind randomized prospective study.
Sample size:
We are planning to detect not less than 30% decrease of rescue propofol consumption when using intranasal dexmedetomidine. Assuming the average propofol consumption for the upper gastrointestinal endoscopy to be 40mg with SD=15mg, the required sample size with 80% power of test is 25 per group at the 0.05 level of significance.
They will be randomly allocated to one of the following study groups:
Group D: Intranasal dexmedetomidine 1.5mcg/kg; Group P: Intranasal saline (placebo)
In addition, rescue sedation will be provided by a patient-controlled sedation using propofol/ alfentanil in both groups. Patient-controlled sedation (PCS) has been shown to provide safe and effective sedation for the individual patient by allowing the patient to decide whether he or she requires sedation and to determine the amount required. PCS has been used for various procedures performed under local and regional anesthesia. PCS with propofol and alfentanil has been used for sedation of patients during endoscopy.
Process Written consent will be signed. No sedative premedication will be prescribed. The patients will be fasted for 6 hours before the procedure. Then patients will be sent to the endoscopy room about 1 hour before the procedure. A nasal catheter is positioned to deliver oxygen if oxygen is needed. Vital signs including heart rate, blood pressure, SpO2 and respiratory rate will be recorded. After obtaining baseline hemodynamic data (NIBP, HR) and respiratory data (SpO2, RR), the patients will be asked to evaluate their baseline levels of anxiety using a numerical rating scale.
The intranasal study drugs will be administrated according to a code on a piece of folded paper drawn randomly from a box. The patients will be randomly allocated to one of the two treatment groups and sedation will be performed 1 hour before the procedure as follows:
- Placebo (0.015ml/kg); D) Intranasal dexmedetomidine 0.015ml/kg
Before study drug administration, patients gently blow their noses. After baseline testing, an investigator who is blind to the study medication will administers the study drug to each naris and the patient remains in a semi-recumbent position with the head of the bed elevated at a 20-40 angle.
After which, measurements including HR, NiBP, SpO2, RR will be recorded every 5 minutes while Numerical Rating Scale of anxiety every 15 minutes. Sedation is evaluated by investigator using Observer Assessment of Alertness/ Sedation (OAA/S]) scale every 15 minutes. Both the investigators and the subjects are blinded to the study medications. The patient will be shown 2 cards of picture about 1 hour after the study drug administration.
An intravenous cannula will be inserted then. The degree of the cannulation pain will be assessed as using NRSpaincannulation. The intravenous cannula is connected to a 50 mL syringe patient-controlled analgesia pump containing 200 mg (20 mL) propofol and 0.5 mg (1 mL) alfentanil, which will be provided as the rescue sedative medications. The drugs are delivered in response to pressure on a hand-held button. Each bolus dose of 0.5 mL delivered contained 4.8 mg propofol and 12 μg alfentanil. No loading dose was used and the lock out time was set at zero. Despite the zero lock out time, a few seconds were required for the pump to deliver the preset bolus. The PCA pump was programmed to deliver a bolus dose of 0.5 ml at 200 ml/h on patient's demand and the pump took 9 s to deliver the bolus, during which time it would not respond to a further demand. Thus, the effective lockout time was 9s. Patients are instructed in the use of the hand-held button before upper endoscopy.
After the cannulation, local anesthetic spray will be administered to the oropharynx or rectum. 10 minutes after the local anesthesia, patient may start to push the button. When the first dose of propofol and alfentanil is infused, patient will be asked whether there is any pain of infusion, and the degree of the pain will be assessed as Numerical Rating Scale of pain due to infusion.
The procedure will be started once the patients feel that they are relaxed. Vital signs including NIBP, SpO2, HR, RR, and OAA/S will be monitored throughout the sedation and procedure process every 5 minutes. If the patient becomes totally unresponsive or any adverse event occurs, the procedure will be stopped. If the SpO2 falls to below 90% for more than 10 seconds, the endoscope will be removed and the patient's vital signs observed, and O2 administered as required by the attending anesthesiologist until the patient becomes responsive again. Once the patient starts responding to command, the procedure will continue. Duration of unresponsiveness would be recorded. The time of start of procedure and duration of procedure and the frequencies of interruption due to patient events will be noted. The PCS propofol and alfentanil will be terminated and disconnected from the patient when the endoscopist indicates that the operative procedure is completed, and the dose consumption recorded. The endoscopist will determine the operating conditions by evaluating the ease of insertion and the patient's lack of motion and ability to obey commands, using NRSsatisfactionendoscopist.
The patients will be transferred to the recovery room for monitoring for 30 minutes. The vital signs (blood pressure, pulse, RR and SpO2, and OAA/S) will be continued every 5 min. When the patients are fully recovered, they will be asked if there is any pain and discomfort and their severity will be assessed as NRSpain and NRSdiscomfort during the procedure. Discomfort is defined as 'a feeling of uneasiness that interfered with the patient's ability to relax'. They will also be asked if they remember any of the following events: the pictures shown to them, the insertion of the endoscope, the discomfort and pain during the examination.
Discharge criteria will be assessed as postanaesthesia discharge score hourly. When the patients are fully recovered, defined as an OAA/S score of 5 and the postanaesthesia score is more than 9, they are fit for discharge. Satisfaction evaluation of sedation will be graded by the patients on NRS in satisfaction patient. They will be questioned on whether they think that they have received an adequate amount of sedation, too little or too much, whether they are relaxed and whether they will undergo the same procedure again.
Data Collection
- Demographic data
- Type of endoscopy
- Duration of sedation
- Duration of procedure
- Duration of recovery area
- Duration from the end of procedure to become fully awake
- Duration at general ward before discharge
- Pain severity (NRS of pain) of cannulation, when being infused of propofol and alfentanil, during the examination
- Vital signs before and during the sedation, during the procedure and Postoperatively (HR, NIBP, SpO2, RR)
- OAA/S before and after administration, during and after procedure
- NRSpain and NRSdiscomfort after administration, during and after procedure
- Time when OAA/S is 4
- Tries and goods of propofol and alfentanil during the procedure
- Propofol and alfentanil consumption
- NRSsatisfactionendoscopist
- NRSsatisfactionpatient
- Adverse events and severity intraoperatively and postoperatively including oversedation, respiratory depression, hypotension, paradoxical reaction, dizziness, nausea and vomiting, bradycardia. The severity of adverse event are graded as follows:
Mild: no treatment Moderate: require treatment Severe: refractory to treatment
Data Analysis Student t test, Mann-Whitney U test and Chi-square test are applied on the analysis.
Study Duration: 18 months. Provide some data on current case load of upper endoscopies in Queen Mary Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: PlaceboNormal saline was given intranasally |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine1.5mcg dexmedetomidine was given intranasally before procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology grade I-III
- 18-60 years old
- Patients having upper endoscopy
Key exclusion criteria (8 listed)
- Clinical history or electrocardiographic evidence of heart block, ischaemic - heart disease, asthma, sleep apnoea syndrome
- BMI > 35kg/m2
- Impaired liver (preoperative serum albumin level less than 30g/L ) or renal function (creatinine >120umol/L)) or known renal or hepatic disease
- Alcohol consumption in excess of 28 units per week
- Pregnancy
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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine (Hospira)Dexmedetomidine 1.5mcg/kg was given intranasally | Drug | Dexmedetomidine |
| PlaceboIntranasal saline was given | Drug | Normal Saline |
Primary outcome
Consumption of Rescue Patient Controlled Propofol
Time frame: Up to 30 minutes during gastrointestinal endoscopy
Until the removal of the endoscopy from the patients
1 secondary outcome
Side Effects of Intrananasal Dexmedetomidine
Time frame: Up to 24 hours after Upper Endoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chi Wai Cheung, MBBS, MD principal investigator
Department of Anaesthesiology, the University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Gastrointestinal Disease, run by The University of Hong Kong.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of Rescue Patient Controlled Propofol (time frame: Up to 30 minutes during gastrointestinal endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.