Monitored Anesthesia CarePhase 2NCT03854812
Magnesium Sulphate Versus Fentanyl Sedation During Burr-hole Surgery
A Phase 2 study testing Magnesium Sulphate, Fentanyl and Propofol in people with Monitored Anesthesia Care, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
MgSO4 was found to reduce the perioperative anesthetic and analgesic requirements when used as an adjuvant to general anesthesia. Fentanyl is a potent opioid and used as adjuvant to other sedatives in awake craniotomy procedure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Monitored Anesthesia Care
- What is being tested?
- Magnesium Sulphate, Fentanyl and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 12 Oct 2019
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with unilateral, chronic subdural hematoma,
- aged above 50 years,
- american society of anesthesiologist-physical status (ASA-PS) grade I-II,
- Glasgow coma scale of 14-15.
Who cannot join
- Patients with hypertension (Systolic blood pressure > 160 mmHg),
- bradycardia (<50 bpm),
- ischemic heart disease,
- second- or third-degree heart block,
- long-term abuse of or addiction to opioids, and sedative-hypnotic drugs (>6 months),
- allergy to study drugs
Show all 11Show fewer
- neuropsychiatric diseases
- patients with predicted difficult airway
- patients with history of obstructive sleep apnea
- patients with deviation in the surgical technique
- inadequacy of local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol for Monitored Anesthesia Care During Burr-hole Surgery for Chronic Subdural Hematoma: Randomized Clinical Trial
MgSO4 was found to reduce the perioperative anesthetic and analgesic requirements when used as an adjuvant to general anesthesia. Fentanyl is a potent opioid and used as adjuvant to other sedatives in awake craniotomy procedure. No study, to the best of our knowledge had evaluated fentanyl continuous infusion, nor MgSo4 infusion as adjuvant sedative agents to propofol during Burr-hole surgery. The aim of this study is to evaluate and compare MgSO4 versus fentanyl continuous infusions for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural hematoma with local infiltration.
Read the detailed description
All participants or their proxy will be informed about the anesthetic techniques and the operative procedure and will provide written informed consent before enrollment in the study.
The eligible patients will be randomly divided by computer designed lists and then will be concealed in closed envelopes into the two study groups. A research assistant who will not be involved in patient management will be responsible for opening the envelope, group assignment and drugs preparation.
Anesthetic management Pre-induction No premedication will be administered. Upon arrival to the operating theater, an intravenous (IV) cannula will be placed, and standard monitors, including 5-lead electrocardiogram, noninvasive arterial blood pressure monitor, and pulse oximetry, will be applied. Oxygen supplementation at fraction of inspired oxygen (FiO2) of 0.35 will be achieved through a suitable air entrainment mask. Bispectral index (BIS: apparatus info) will be applied before starting the drug infusions and will be used for maintenance of sedation during operation.
Induction of anesthesia Group M (n=17): will receive a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution Group F (n=17): will receive a loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution Both groups will be given 0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80.
Intraoperative management After achieving the target sedation level (RSS of 3), surgeons will infiltrate the surgical site with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline at least 5 minutes before surgical incision. After performing burr-hole craniotomy soaked pledgets with lidocaine will be applied to anaesthetize the dura, the dura will be then opened, and the hematoma will be evacuated. The Infusion of sedatives will be ceased after skin closure.
Intraoperative patient's movements (defined as those which may interfere with the surgical conduct such as twisting of hand and/or leg and head mobility) will be managed by reassurance and support for 30 seconds. However, when movements continue, a bolus dose of propofol of 0.5 mg/kg will be given then infusion dose will be increased till the maximum dose (2.5mg/kg/hr) to regain BIS sedation score between 60-80. If the patient starts to move again the same sequence will be repeated. Minute movements of other body parts as well as movements of fingers or toes that unlikely to hinder the operative intervention, will be deemed insignificant to be documented.
Induction of general anesthesia will be only indicated if satisfactory surgical conditions will not be attained by the rescue propofol.
Intraoperative bradycardia and tachycardia (defined as heart rate (HR) < 45 bpm or > 120 bpm respectively) will be treated with intravenous atropine 0.2 mg, or propranolol 0.5-1 mg respectively. Hypertension and hypotension (defined as a more than 25% increase or decrease from baseline respectively) will be treated with nitroglycerine (0.1-10 mcg/min) or ephedrine (5 mg) respectively.
Postoperative management All patients will be transferred to the post-anesthesia care unit (PACU) after surgery where they will be closely monitored with the aid of five-lead electrocardiography and non-invasive arterial blood pressure, peripheral oxygen saturation (SpO2), and respiratory rate readings using an automated system for 24 h after surgery. Postoperative pain intensity will be assessed using VAS score at 1, 2, 3 and 6 hours after PACU admission. If VAS score exceeds 3, 30 mg of ketorolac will be administered.
- Conditions
- Monitored Anesthesia Care
- Keywords
- magnesium sulphate, fentanyl, propofol, monitored anesthesia care, burr-hole evacuation, chronic subdural hematoma
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulphateDrug
Also called magnesium sulfate
a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution
FentanylDrug
loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution
PropofolDrug
0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | magnesium sulphate as adjuvant to propofol Receives: Drug: Magnesium Sulphate; Drug: Propofol |
| Group F | Active comparator | fentanyl as adjuvant to propofol Receives: Drug: Fentanyl; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
average systolic blood pressure
mmgh
Measured: after induction of conscious sedation till end of procedure
Secondary outcomes (12)
ephedrine use
mg
Measured: after induction of conscious sedation till end of procedure
Total amount of Propofol consumption
mg
Measured: after induction of conscious sedation till end of procedure
Total number of intraoperative patient's movements
defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head
Measured: after induction of conscious sedation till end of procedure
Systolic blood pressure
mmgh
Measured: upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU
Diastolic blood pressure
mmgh
Measured: upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU
Heart rate
bpm
Measured: upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU
Surgeon satisfaction score
1, extremely dissatisfied; 2, not satisfied but able to manage; 3, satisfied; 4, extremely satisfied.
Measured: 30 minutes after the end of the surgery
Ramsay sedation scale
Ramsey 1 Anxious, agitated, restless Ramsey 2 Cooperative, oriented, tranquil Ramsey 3 Responsive to commands only If Asleep Ramsey 4 Brisk response to light glabellar tap or loud auditory stimulus Ramsey 5 Sluggish response to light glabellar tap or loud auditory stimulus Ramsey 6 No response to light glabellar tap or loud auditory stimulus
Measured: 15 and 30 minutes postoperative
Visual Analogue Scale (VAS) for pain
10 cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0=no pain at all and 10 cm = worst pain imaginable."
Measured: at 15 minutes, 30 minutes, 1hr, 2 hrs. 3hrs and 6 hrs after PACU admission
atropine use
mg
Measured: after induction of conscious sedation till end of procedure
first rescue analgesic during 1 hour post operative
incidence of patients requiring analgesics
Measured: 1 hour postoperative
postoperative nausea and vomiting
incidence
Measured: first 24 hours in the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Mar 2019
- Primary completion12 Oct 2019
- Study completion12 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Monitored Anesthesia CareStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
- Investigators
- Maha mostafa, MD, Principal investigator, kasr el aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854812
- Sponsor's protocol ID
- N28-2018
- Status last verified
- Apr 2021
- First submitted
- 24 Feb 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rodriguez-Rubio L, Nava E, Del Pozo JSG, Jordan J. Influence of the perioperative administration of magnesium sulfate on the total dose of anesthetics during general anesthesia. A systematic review and meta-analysis. J Clin Anesth. 2017 Jun;39:129-138. doi: 10.1016/j.jclinane.2017.03.038. Epub 2017 Apr 7.
PubMed 28494889Sinha PK, Koshy T, Gayatri P, Smitha V, Abraham M, Rathod RC. Anesthesia for awake craniotomy: a retrospective study. Neurol India. 2007 Oct-Dec;55(4):376-81. doi: 10.4103/0028-3886.33308.
PubMed 18040111Gignac E, Manninen PH, Gelb AW. Comparison of fentanyl, sufentanil and alfentanil during awake craniotomy for epilepsy. Can J Anaesth. 1993 May;40(5 Pt 1):421-4. doi: 10.1007/BF03009510.
PubMed 8513521
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol for Monitored Anesthesia Care During Burr-hole Surgery for Chronic Subdural Hematoma: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03854812
- Acronym / sponsor ID
- N28-2018
- Conditions
- Monitored Anesthesia Care
- Keywords
- magnesium sulphate, fentanyl, propofol, monitored anesthesia care, burr-hole evacuation, chronic subdural hematoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 12 Oct 2019 (actual)
- Study completion
- 12 Oct 2019 (actual)
- First posted
- 26 Feb 2019 (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.
MgSO4 was found to reduce the perioperative anesthetic and analgesic requirements when used as an adjuvant to general anesthesia. Fentanyl is a potent opioid and used as adjuvant to other sedatives in awake craniotomy procedure. No study, to the best of our knowledge had evaluated fentanyl continuous infusion, nor MgSo4 infusion as adjuvant sedative agents to propofol during Burr-hole surgery. The aim of this study is to evaluate and compare MgSO4 versus fentanyl continuous infusions for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural hematoma with local infiltration.
Detailed description
All participants or their proxy will be informed about the anesthetic techniques and the operative procedure and will provide written informed consent before enrollment in the study.
The eligible patients will be randomly divided by computer designed lists and then will be concealed in closed envelopes into the two study groups. A research assistant who will not be involved in patient management will be responsible for opening the envelope, group assignment and drugs preparation.
Anesthetic management Pre-induction No premedication will be administered. Upon arrival to the operating theater, an intravenous (IV) cannula will be placed, and standard monitors, including 5-lead electrocardiogram, noninvasive arterial blood pressure monitor, and pulse oximetry, will be applied. Oxygen supplementation at fraction of inspired oxygen (FiO2) of 0.35 will be achieved through a suitable air entrainment mask. Bispectral index (BIS: apparatus info) will be applied before starting the drug infusions and will be used for maintenance of sedation during operation.
Induction of anesthesia Group M (n=17): will receive a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution Group F (n=17): will receive a loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution Both groups will be given 0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80.
Intraoperative management After achieving the target sedation level (RSS of 3), surgeons will infiltrate the surgical site with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline at least 5 minutes before surgical incision. After performing burr-hole craniotomy soaked pledgets with lidocaine will be applied to anaesthetize the dura, the dura will be then opened, and the hematoma will be evacuated. The Infusion of sedatives will be ceased after skin closure.
Intraoperative patient's movements (defined as those which may interfere with the surgical conduct such as twisting of hand and/or leg and head mobility) will be managed by reassurance and support for 30 seconds. However, when movements continue, a bolus dose of propofol of 0.5 mg/kg will be given then infusion dose will be increased till the maximum dose (2.5mg/kg/hr) to regain BIS sedation score between 60-80. If the patient starts to move again the same sequence will be repeated. Minute movements of other body parts as well as movements of fingers or toes that unlikely to hinder the operative intervention, will be deemed insignificant to be documented.
Induction of general anesthesia will be only indicated if satisfactory surgical conditions will not be attained by the rescue propofol.
Intraoperative bradycardia and tachycardia (defined as heart rate (HR) < 45 bpm or > 120 bpm respectively) will be treated with intravenous atropine 0.2 mg, or propranolol 0.5-1 mg respectively. Hypertension and hypotension (defined as a more than 25% increase or decrease from baseline respectively) will be treated with nitroglycerine (0.1-10 mcg/min) or ephedrine (5 mg) respectively.
Postoperative management All patients will be transferred to the post-anesthesia care unit (PACU) after surgery where they will be closely monitored with the aid of five-lead electrocardiography and non-invasive arterial blood pressure, peripheral oxygen saturation (SpO2), and respiratory rate readings using an automated system for 24 h after surgery. Postoperative pain intensity will be assessed using VAS score at 1, 2, 3 and 6 hours after PACU admission. If VAS score exceeds 3, 30 mg of ketorolac will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: Magnesium Sulphate, Drug: Propofolmagnesium sulphate as adjuvant to propofol |
| Group F | Active comparator | Drug: Fentanyl, Drug: Propofolfentanyl as adjuvant to propofol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with unilateral, chronic subdural hematoma,
- aged above 50 years,
- american society of anesthesiologist-physical status (ASA-PS) grade I-II,
- Glasgow coma scale of 14-15.
Key exclusion criteria (11 listed)
- Patients with hypertension (Systolic blood pressure > 160 mmHg),
- bradycardia (<50 bpm),
- ischemic heart disease,
- second- or third-degree heart block,
- long-term abuse of or addiction to opioids, and sedative-hypnotic drugs (>6 months),
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 |
|---|---|---|
| Magnesium SulphateAlso: magnesium sulfatea loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution | Drug | Group M |
| Fentanylloading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution | Drug | Group F |
| Propofol0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80 | Drug | Group F, Group M |
Primary outcome
average systolic blood pressure
Time frame: after induction of conscious sedation till end of procedure
mmgh
12 secondary outcomes
ephedrine use
Time frame: after induction of conscious sedation till end of procedure
Total amount of Propofol consumption
Time frame: after induction of conscious sedation till end of procedure
Total number of intraoperative patient's movements
Time frame: after induction of conscious sedation till end of procedure
Systolic blood pressure
Time frame: upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU
Diastolic blood pressure
Time frame: upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU
Heart rate
Time frame: upon arrival at the operating room, after induction of conscious sedation, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival at PACU, 5,10,15,30 min and 1 hour at the PACU
Surgeon satisfaction score
Time frame: 30 minutes after the end of the surgery
Ramsay sedation scale
Time frame: 15 and 30 minutes postoperative
Visual Analogue Scale (VAS) for pain
Time frame: at 15 minutes, 30 minutes, 1hr, 2 hrs. 3hrs and 6 hrs after PACU admission
atropine use
Time frame: after induction of conscious sedation till end of procedure
first rescue analgesic during 1 hour post operative
Time frame: 1 hour postoperative
postoperative nausea and vomiting
Time frame: first 24 hours in the postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 28494889Rodriguez-Rubio L, Nava E, Del Pozo JSG, Jordan J. Influence of the perioperative administration of magnesium sulfate on the total dose of anesthetics during general anesthesia. A systematic review and meta-analysis. J Clin Anesth. 2017 Jun;39:129-138. doi: 10.1016/j.jclinane.2017.03.038. Epub 2017 Apr 7.
- Background: PubMed 18040111Sinha PK, Koshy T, Gayatri P, Smitha V, Abraham M, Rathod RC. Anesthesia for awake craniotomy: a retrospective study. Neurol India. 2007 Oct-Dec;55(4):376-81. doi: 10.4103/0028-3886.33308.
- Background: PubMed 8513521Gignac E, Manninen PH, Gelb AW. Comparison of fentanyl, sufentanil and alfentanil during awake craniotomy for epilepsy. Can J Anaesth. 1993 May;40(5 Pt 1):421-4. doi: 10.1007/BF03009510.
- Individual participant dataSharing planned: Undecided
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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.
Maha mostafa, MD principal investigator
kasr el aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium Sulphate, Fentanyl and Propofol in people with Monitored Anesthesia Care, run by Kasr El Aini Hospital at 1 site in Egypt.
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 11 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 13 Apr 2021. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
average systolic blood pressure (time frame: after induction of conscious sedation till end of procedure). 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 NCT03854812, which also lists 3 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 13 Apr 2021.