Lack of Drug ActionPhase 3NCT02684019
Goal Directed Propofol Sedation With Magnesium Sulphate Versus Dexmedetomidine for ERCP Procedure
A Phase 3 study testing Dexmedetomidine and Magnesium Sulphate in people with Lack of Drug Action, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging from conscious to deep sedation leading to general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Lack of Drug Action
- What is being tested?
- Dexmedetomidine and Magnesium Sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Nov 2016
- Phase
- Phase 3
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I, II or III.
- Body mass index (BMI) ˂30
- Patients scheduled for ERCP procedures
Who cannot join
- Obesity (BMI >30)
- Evidence of hepatic encephalopathy, ascites.
- Sever renal, endocrine and respiratory dysfunction.
- Atrioventricular conductance disturbance.
- Symptomatic bradycardia <35 bpm
- Hemodynamically unstable patients on inotropic support.
Show all 13Show fewer
- Neurological disorders
- Myasthenia gravis.
- Hypo/Hyperkalemia (Potassium <3meq/l or>5.5meq/l) (risk of dysrhythmias).
- Chronic treatment with calcium channel blockers or magnesium
- Opioid or analgesic abuse
- Allergy to Propofol/ egg or any other study drugs.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging from conscious to deep sedation leading to general anesthesia.
Propofol sedation for (ERCP) procedures is the most popular current technique that has generated controversy in the medical field. Propofol can be safely administered because of its shorter half-life which results in a shorter recovery time than conventional sedation (opioid and/or benzodiazepine) that makes it widely used for sedation in many gastrointestinal procedures including ERCP. However, because of its narrow therapeutic window, the level of conscious sedation can easily go deeper from moderately deep sedation to near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and apnea. Depth of sedation could be estimated better when target effect concentration of propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a specific range ensures additional safety during the procedure. Scores between 60-80 have been recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg. Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties with opioid and anesthetic sparing effects, without clinically significant respiratory depression.
Read more
Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it reduced their requirements intraoperatively and can help supplement analgesia postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .
Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients .
Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost and complications together with more patient and doctor satisfaction in addition to better patient outcome.
Read the detailed description
After Theodor Bilharz Research Institute (TBRI) Ethics Committee approval, sixty patients scheduled for ERCP procedures will be informed about the study and written consents will be obtained.
Patients will be allocated into two groups, thirty patients each, Magnesium (M) and Dexmedetomidine (D). Group (M) will receive 40 mg.kg-1 of magnesium sulphate bolus followed by IV infusion of 10 mg.kg-1.h-1. Group (D) will receive dexmedetomidine bolus (1μg.kg-1) followed by infusion of 0.5μg.kg-1h-1 all through the procedure.
Randomization of the patients will be established by computer generated random number table utilizing sealed envelope technique.
On arrival to the ERCP suit, two IV cannulae will be inserted in both hands of each patient in both groups. One for isotonic saline infusion and propofol administration and the other will be preserved for the study drug administration. IV fluid will be started at a rate of 8-12 ml.kg-1.h-1 continued throughout the procedure. All patients will be premedicated with intravenous pantoprazole 40mg and ondansetron 8mg.
Routine monitoring of ECG, pulse oximetry, non-invasive blood pressure will be established before induction of sedation. BIS three electrodes sensor will be applied over the patient's forehead using fronto-temporal montage for the monitoring of level of sedation . The baseline variables will be recorded and documented as well as continuous monitoring and documentation every 5 min for the first 30 min and every 10 min till the end of procedure. Supplemental oxygen will be administered with nasal prongs at 3 l.min-1. The total duration of the procedure, defined as the time taken from insertion of the endoscope to its removal, will also be documented.
Each study drug will be loaded in 50 ml syringes (for both bolus and infusion) \& labeled as "study drug bolus" and "study drug infusion". The identity of the constituted drug in the syringe is not revealed to the anesthetist handling the patients and the observer recording the post procedure variables. Depending upon the body weight, each patient will receive a bolus of the study drug, diluted up to 50 ml with saline (direct IV)followed by infusion of the same drug in another 50 ml using a syringe pump. Each bolus will be given and the rate of drug infusion will be adjusted by the anesthesia resident not involved in the study.
The study drugs IV infusions will be administered using injector pumps with unidentified screen to assure that the observer remains blinded.
For each patient, bolus dose of the each study drug will be administered slowly over 10 min, after mouth gag insertion and patient positioning (either lateral or prone position) followed by induction with propofol in a dose of 0.5-1.5 mgkg-1, targeting BIS between 60-70.Once the target BIS is attained, the infusion of the study drug is started with the pre-adjusted rate (discussed before) along with the propofol maintenance infusion starting at a rate of 3 mg/kg/hr to be adjusted to maintain a BIS value between 60-70.At the end of the procedure, propofol and study drug infusions will be stopped. BIS values will be allowed equilibrating above 80. Patients oropharynx will be thoroughly suctioned and patients will be turned supine with head up tilt (15 degrees), to allow for complete recovery with eye opening on command, ability to handle secretions, follow simple commands, hemodynamic stability, maintaining O2 saturation at room air >95% and attainment of BIS value >90 as end points
- Conditions
- Lack of Drug Action
- Being tested
- Dexmedetomidine, Magnesium Sulphate
- Keywords
- Endoscopic retrograde cholangiopancreatography, sedation, dexmedetomidine, propofol, Magnesium sulphate, Bispectral index monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
added to propofol sedation
Magnesium SulphateDrug
added to propofol sedation
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | 1microgram/kilogram loading dose followed by 0.5 microgram/kilogram/hour IV Receives: Drug: Dexmedetomidine |
| Magnesium sulphate | Active comparator | 40milligram/kilogram loading dose followed by 10milligram/kilogram/hour IV Receives: Drug: Magnesium Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total propofol consumption
0.5-1.5 mg as induction dose guided by bispectral index between 60-70 followed by infusion ranged from 3-5 mg/kg/h keeping BIS between 60-70
Measured: through study completion, an average of one hour
Secondary outcomes (5)
Mean arterial blood pressure
Every 5 min for the first 30 min and every 10 min till the end of procedure.Every 15 min in post-anesthesia care unit
Measured: through study completion, an average of one hour
Time to discharge
Time to reach modified Aldrete score more than 9
Measured: 15 minutes
Cost
The sum of all the drugs costs
Measured: through study completion , an average of one hour
Complication and side effects
dizziness, vomiting or headache
Measured: through study completion , an average of one hour
Heart rate
Every 5 min for the first 30 min and every 10 min till the end of procedure.Every 15 min in post-anesthesia care unit
Measured: through study completion, an average of one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lack of Drug ActionStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group M: the Drug consisted of 2 ampoules each one containing 2500 mg magnesium sulphate (Egypt Otsuka pharma.Co)in 50 ml syringe .(i.e. 100 mg/ml). Loading dose was 40mg/kg, given over 10min and maintenance dose was 10mg/kg/h. Group D: the Drug consisted of 2ml containing 200μg Dexmedetomidine (precedex®; united pharmaceutical group company, USA) diluted up to 50ml with normal saline (4μg/ml). Loading dose was 1μg/kg; given over 10min. The maintenance dose was 0.5 μg / kg / h.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalda G Moustafa, Theodor Bilharz Research Institute
- Investigators
- Hend H Kamel, Professor, Study chair, Theodor Bilharz Research InstituteMaher F Mahmoud, Professor, Study chair, Kasr El Aini hospital,Faculty of medicine, Cairo University,Eslam A Mohamed, Lecturer, Principal investigator, Kasr El Aini hospital,Faculty of medicine, Cairo University,Nabaweya M Kamal, Professor, Study director, Theodor Bilharz Research InstituteMohammed A Maher, Lecturer, Principal investigator, Theodor Bilharz Research InstituteAhmed S Abd El Azeem, Residant, Principal investigator, Theodor Bilharz Research InstituteKhalda G Radwan, Professor, Study director, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684019
- Sponsor's protocol ID
- TBRI project (code number111A)
- Status last verified
- Oct 2020
- First submitted
- 6 Feb 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeurnink SM, Steyerberg E, Kuipers E, Siersema P. The burden of endoscopic retrograde cholangiopancreatography (ERCP) performed with the patient under conscious sedation. Surg Endosc. 2012 Aug;26(8):2213-9. doi: 10.1007/s00464-012-2162-2.
PubMed 22302536Ramkiran S, Iyer SS, Dharmavaram S, Mohan CV, Balekudru A, Kunnavil R. BIS Targeted Propofol Sparing Effects of Dexmedetomidine Versus Ketamine in Outpatient ERCP: A Prospective Randomised Controlled Trial. J Clin Diagn Res. 2015 May;9(5):UC07-12. doi: 10.7860/JCDR/2015/12435.5991. Epub 2015 May 1.
PubMed 26155536Fluhr G, Mayerle J, Weber E, Aghdassi A, Simon P, Gress T, Seufferlein T, Mossner J, Stallmach A, Rosch T, Muller M, Siegmund B, Buchner-Steudel P, Zuber-Jerger I, Kantowski M, Hoffmeister A, Rosendahl J, Linhart T, Maul J, Czako L, Hegyi P, Kraft M, Engel G, Kohlmann T, Glitsch A, Pickartz T, Budde C, Nitsche C, Storck K, Lerch MM. Pre-study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis. BMC Gastroenterol. 2013 Jan 15;13:11. doi: 10.1186/1471-230X-13-11.
PubMed 23320650James MF. Clinical use of magnesium infusions in anesthesia. Anesth Analg. 1992 Jan;74(1):129-36. doi: 10.1213/00000539-199201000-00021. No abstract available.
PubMed 1734773Wang D, Chen C, Chen J, Xu Y, Wang L, Zhu Z, Deng D, Chen J, Long A, Tang D, Liu J. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One. 2013;8(1):e53311. doi: 10.1371/journal.pone.0053311. Epub 2013 Jan 8.
PubMed 23308191Mukhopadhyay S, Niyogi M, Sarkar J, Mukhopadhyay BS, Halder SK. The dexmedetomidine "augmented" sedato analgesic cocktail: An effective approach for sedation in prolonged endoscopic retrograde cholangio-pancreatography. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):201-6. doi: 10.4103/0970-9185.155149.
PubMed 25948901
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Propofol Sedation With Magnesium Sulphate Versus Dexmedetomidine for ERCP Procedure
- ClinicalTrials.gov ID
- NCT02684019
- Acronym / sponsor ID
- TBRI project (code number111A)
- Conditions
- Lack of Drug Action
- Keywords
- Endoscopic retrograde cholangiopancreatography, sedation, dexmedetomidine, propofol, Magnesium sulphate, Bispectral index monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Feb 2016 (estimated)
- 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.
Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging from conscious to deep sedation leading to general anesthesia.
Propofol sedation for (ERCP) procedures is the most popular current technique that has generated controversy in the medical field. Propofol can be safely administered because of its shorter half-life which results in a shorter recovery time than conventional sedation (opioid and/or benzodiazepine) that makes it widely used for sedation in many gastrointestinal procedures including ERCP. However, because of its narrow therapeutic window, the level of conscious sedation can easily go deeper from moderately deep sedation to near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and apnea. Depth of sedation could be estimated better when target effect concentration of propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a specific range ensures additional safety during the procedure. Scores between 60-80 have been recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg. Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties with opioid and anesthetic sparing effects, without clinically significant respiratory depression.
Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it reduced their requirements intraoperatively and can help supplement analgesia postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .
Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients .
Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost and complications together with more patient and doctor satisfaction in addition to better patient outcome.
Detailed description
After Theodor Bilharz Research Institute (TBRI) Ethics Committee approval, sixty patients scheduled for ERCP procedures will be informed about the study and written consents will be obtained.
Patients will be allocated into two groups, thirty patients each, Magnesium (M) and Dexmedetomidine (D). Group (M) will receive 40 mg.kg-1 of magnesium sulphate bolus followed by IV infusion of 10 mg.kg-1.h-1. Group (D) will receive dexmedetomidine bolus (1μg.kg-1) followed by infusion of 0.5μg.kg-1h-1 all through the procedure.
Randomization of the patients will be established by computer generated random number table utilizing sealed envelope technique.
On arrival to the ERCP suit, two IV cannulae will be inserted in both hands of each patient in both groups. One for isotonic saline infusion and propofol administration and the other will be preserved for the study drug administration. IV fluid will be started at a rate of 8-12 ml.kg-1.h-1 continued throughout the procedure. All patients will be premedicated with intravenous pantoprazole 40mg and ondansetron 8mg.
Routine monitoring of ECG, pulse oximetry, non-invasive blood pressure will be established before induction of sedation. BIS three electrodes sensor will be applied over the patient's forehead using fronto-temporal montage for the monitoring of level of sedation . The baseline variables will be recorded and documented as well as continuous monitoring and documentation every 5 min for the first 30 min and every 10 min till the end of procedure. Supplemental oxygen will be administered with nasal prongs at 3 l.min-1. The total duration of the procedure, defined as the time taken from insertion of the endoscope to its removal, will also be documented.
Each study drug will be loaded in 50 ml syringes (for both bolus and infusion) \& labeled as "study drug bolus" and "study drug infusion". The identity of the constituted drug in the syringe is not revealed to the anesthetist handling the patients and the observer recording the post procedure variables. Depending upon the body weight, each patient will receive a bolus of the study drug, diluted up to 50 ml with saline (direct IV)followed by infusion of the same drug in another 50 ml using a syringe pump. Each bolus will be given and the rate of drug infusion will be adjusted by the anesthesia resident not involved in the study.
The study drugs IV infusions will be administered using injector pumps with unidentified screen to assure that the observer remains blinded.
For each patient, bolus dose of the each study drug will be administered slowly over 10 min, after mouth gag insertion and patient positioning (either lateral or prone position) followed by induction with propofol in a dose of 0.5-1.5 mgkg-1, targeting BIS between 60-70.Once the target BIS is attained, the infusion of the study drug is started with the pre-adjusted rate (discussed before) along with the propofol maintenance infusion starting at a rate of 3 mg/kg/hr to be adjusted to maintain a BIS value between 60-70.At the end of the procedure, propofol and study drug infusions will be stopped. BIS values will be allowed equilibrating above 80. Patients oropharynx will be thoroughly suctioned and patients will be turned supine with head up tilt (15 degrees), to allow for complete recovery with eye opening on command, ability to handle secretions, follow simple commands, hemodynamic stability, maintaining O2 saturation at room air >95% and attainment of BIS value >90 as end points
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group M: the Drug consisted of 2 ampoules each one containing 2500 mg magnesium sulphate (Egypt Otsuka pharma.Co)in 50 ml syringe .(i.e. 100 mg/ml). Loading dose was 40mg/kg, given over 10min and maintenance dose was 10mg/kg/h. Group D: the Drug consisted of 2ml containing 200μg Dexmedetomidine (precedex®; united pharmaceutical group company, USA) diluted up to 50ml with normal saline (4μg/ml). Loading dose was 1μg/kg; given over 10min. The maintenance dose was 0.5 μg / kg / h.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine1microgram/kilogram loading dose followed by 0.5 microgram/kilogram/hour IV |
| Magnesium sulphate | Active comparator | Drug: Magnesium Sulphate40milligram/kilogram loading dose followed by 10milligram/kilogram/hour IV |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) I, II or III.
- Body mass index (BMI) ˂30
- Patients scheduled for ERCP procedures
Key exclusion criteria (13 listed)
- Obesity (BMI >30)
- Evidence of hepatic encephalopathy, ascites.
- Sever renal, endocrine and respiratory dysfunction.
- Atrioventricular conductance disturbance.
- Symptomatic bradycardia <35 bpm
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: Precedexadded to propofol sedation | Drug | Dexmedetomidine |
| Magnesium Sulphateadded to propofol sedation | Drug | Magnesium sulphate |
Primary outcome
Total propofol consumption
Time frame: through study completion, an average of one hour
0.5-1.5 mg as induction dose guided by bispectral index between 60-70 followed by infusion ranged from 3-5 mg/kg/h keeping BIS between 60-70
5 secondary outcomes
Mean arterial blood pressure
Time frame: through study completion, an average of one hour
Time to discharge
Time frame: 15 minutes
Cost
Time frame: through study completion , an average of one hour
Complication and side effects
Time frame: through study completion , an average of one hour
Heart rate
Time frame: through study completion, an average of one hour
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 19 Oct 2020.
- Results publication: PubMed 22302536Jeurnink SM, Steyerberg E, Kuipers E, Siersema P. The burden of endoscopic retrograde cholangiopancreatography (ERCP) performed with the patient under conscious sedation. Surg Endosc. 2012 Aug;26(8):2213-9. doi: 10.1007/s00464-012-2162-2.
- Results publication: PubMed 26155536Ramkiran S, Iyer SS, Dharmavaram S, Mohan CV, Balekudru A, Kunnavil R. BIS Targeted Propofol Sparing Effects of Dexmedetomidine Versus Ketamine in Outpatient ERCP: A Prospective Randomised Controlled Trial. J Clin Diagn Res. 2015 May;9(5):UC07-12. doi: 10.7860/JCDR/2015/12435.5991. Epub 2015 May 1.
- Results publication: PubMed 23320650Fluhr G, Mayerle J, Weber E, Aghdassi A, Simon P, Gress T, Seufferlein T, Mossner J, Stallmach A, Rosch T, Muller M, Siegmund B, Buchner-Steudel P, Zuber-Jerger I, Kantowski M, Hoffmeister A, Rosendahl J, Linhart T, Maul J, Czako L, Hegyi P, Kraft M, Engel G, Kohlmann T, Glitsch A, Pickartz T, Budde C, Nitsche C, Storck K, Lerch MM. Pre-study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis. BMC Gastroenterol. 2013 Jan 15;13:11. doi: 10.1186/1471-230X-13-11.
- Results publication: PubMed 1734773James MF. Clinical use of magnesium infusions in anesthesia. Anesth Analg. 1992 Jan;74(1):129-36. doi: 10.1213/00000539-199201000-00021. No abstract available.
- Results publication: PubMed 23308191Wang D, Chen C, Chen J, Xu Y, Wang L, Zhu Z, Deng D, Chen J, Long A, Tang D, Liu J. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One. 2013;8(1):e53311. doi: 10.1371/journal.pone.0053311. Epub 2013 Jan 8.
- Results publication: PubMed 25948901Mukhopadhyay S, Niyogi M, Sarkar J, Mukhopadhyay BS, Halder SK. The dexmedetomidine "augmented" sedato analgesic cocktail: An effective approach for sedation in prolonged endoscopic retrograde cholangio-pancreatography. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):201-6. doi: 10.4103/0970-9185.155149.
- Individual participant dataSharing planned: No
Related trials for Lack of Drug Action
RecruitingPhase 2
Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:
Pharmacogenomic Drug Interaction, Side Effect of Drug
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.
Hend H Kamel, Professor study chair
Theodor Bilharz Research Institute
Maher F Mahmoud, Professor study chair
Kasr El Aini hospital,Faculty of medicine, Cairo University,
Eslam A Mohamed, Lecturer principal investigator
Kasr El Aini hospital,Faculty of medicine, Cairo University,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Magnesium Sulphate in people with Lack of Drug Action, run by Theodor Bilharz Research Institute 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 3 inclusion and 13 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 19 Oct 2020. 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 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?
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?
Total propofol consumption (time frame: through study completion, an average of one hour). 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 NCT02684019, which also lists 6 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 19 Oct 2020.