Conscious SedationPhase 2CSDHNCT03548493
Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH
A Phase 2 study testing Magnesium sulphate, Fentanyl and Propofol in people with Conscious Sedation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Conscious Sedation
- 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
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2018to 9 Aug 2018
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 50 years
- ASA (American Society of Anesthesiologists physical status) grade I to II
- Glasgow coma scale 14-15
- Unilateral chronic subdural hematoma
Who cannot join
- Hypertension (diastolic blood pressure > 160 mmHg)
- Bradycardia (<50 bpm)
- Ischemic heart disease (<6 months)
- Second- or third-degree heart block
- Long-term abuse of or addiction to alcohol, tobacco, opioids, and sedative-hypnotic drugs (>6 months)
- Allergy to study drugs
Show all 9Show fewer
- Neuropsychiatric diseases
- Predicted difficult airway according to Ganzouri score >4.
- Patients with deviation in the surgical technique or with inadequacy of local anesthesia were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol Xylocaine Combination for Conscious Sedation During Chronic Subdural Haematoma Surgery. Comparative Study
The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.
Read the detailed description
Following institutional ethical committee approval, 34 patients undergoing burr-hole surgery for chronic subdural hemorrhage were included in this prospective, randomized, double-blind study.
Written informed consent were obtained from all subjects before enrollment in the study.
During the preanesthetic checkup,the operative procedure and anesthetic techniques were explained to all patients.
Upon arrival to operating theater, standard monitoring were applied to all patients and bispectral index was applied before starting the drug infusions and was used for maintenance of sedation during operation.
Subjects were randomized into 2 groups. Magnesium (M) group received Magnesium sulphate 50mg/kg IV over 15 minutes Followed by continuous infusion at 15 mg/kg/h Fentanyl (F) group received fentanyl 1 μg /kg IV bolus over 15 minutes Followed by continuous infusion starting at 0.5 μg /kg/h Loading and infusion doses of magnesium sulphate and loading doses of fentanyl were chosen from previous studies.
In both groups fentanyl and magnesium sulphate were accompanied by IV propofol at a dose of 50- 150 μg /kg/min bolus over 10 minutes to achieve target sedation level, that is, Ramsay sedation scale (RSS) 3, if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol were given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80 After achieving predefined target sedation level (RSS of 3), surgeons infiltrated the sites of the burrholes with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline infiltrated locally at least 5 minutes before surgical incision. After burr-hole craniotomy followed by the hematoma evacuation is accomplished, the Infusion of sedatives were discontinued just after placement of the final skin suture.
Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head were recorded. The first intervention is to attempt patient reassurance for 30 seconds. If movement continues then the bolus dose of propofol of 0.5 mg/kg was given and infusion dose was increased in the previously described manner till the maximum dose to regain BIS sedation score between 60-80.
If the patient starts to move again the same sequence was repeated. Induction of general anesthesia was deemed the final intervention in case satisfactory condition was not achieved within the rescue propofol.
All patients were transferred to the post-anesthesia care unit (PACU) after surgery.
The data collected are:
- Total amount of Propofol consumption.
- Total number of patient movements
- The intraoperative and postoperative hemodynamic data
- VAS (Visual analogue scale for pain) score
- Time to first rescue analgesic
- Adverse events
- Surgeon satisfaction score was recorded.
Statistical analysis:
Data was analyzed using SPSS © Statistics version 23 (IBM© Corp., Armonk, NY, USA). Chi-square test (Fisher's exact test) was used to examine the relation between qualitative variables. For quantitative data, comparison between the two groups was done using independent sample t-test or Mann-Whitney test as appropriate. All tests were two-tailed. A p-value < 0.05 was considered significant.
Sample Size calculation:
A previous study reported that pre-procedure magnesium sulphate reduced the total propofol requirements to 130±19.09 mg compared to 172.8±29.09 mg with pre-procedure fentanyl. Based on these results, a sample size of 15 cases in each group was satisfactory to elicit the difference at an alpha level of 0.05 and a power of the test of 95%. The sample size was increased to 17 per group to compensate for possible dropouts.
- Conditions
- Conscious Sedation
- Keywords
- Magnesium sulphate, Fentanyl, Conscious sedation, chronic subdural haematoma, Propofol, Burr hole
- 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
Magnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h
FentanylDrug
Fentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h
PropofolDrug
In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%
| Study group | Role | What they receive |
|---|---|---|
| Magnesium (M) group | Experimental | Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation Receives: Drug: Magnesium sulphate; Drug: Propofol |
| Fentanyl (F) group | Active comparator | Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation Receives: Drug: Fentanyl; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of Propofol consumption in each group
To measure total amount of propofol consumption from induction of conscious sedation till the end of the operation and to compare it between both groups
Measured: From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery
Secondary outcomes (6)
To measure the total number of intraoperative patient's movements
Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head
Measured: From the start of the surgery and throughout the duration of the surgery
Heart rate
Heart rate in beats/min
Measured: Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
Non invasive blood pressure
Systolic and diastolic blood pressure in mmhg
Measured: Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
To assess surgeon satisfaction score
Surgeon satisfaction was assessed as follows: 1, extremely dissatisfied; 2, not satisfied but able to manage; 3, satisfied; 4, extremely satisfied.
Measured: 30 minutes after the end of the surgery
VAS score for pain
The pain VAS is a unidimensional measure of pain intensity, the score is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Measured: at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.
Time to first rescue analgesic
The time when the patient first requires analgesia.
Measured: During the 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 posted7 Jun 2018
- Study start10 Apr 2018
- Primary completion8 Aug 2018
- Study completion9 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Conscious SedationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 34 patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: 1. Group A (n=17) will receive magnesium sulphate adjuvant to propofol for sedation. 2. Group B (n=17) will receive fentanyl adjuvant to propofol for sedation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Samir Fahmy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548493
- Sponsor's protocol ID
- N-28-2018
- Acronym
- CSDH
- Status last verified
- Dec 2018
- First submitted
- 12 May 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guzel A, Kaya S, Ozkan U, Ufuk Aluclu M, Ceviz A, Belen D. Surgical treatment of chronic subdural haematoma under monitored anaesthesia care. Swiss Med Wkly. 2008 Jul 12;138(27-28):398-403. doi: 10.4414/smw.2008.12121.
PubMed 18642135Bishnoi V, Kumar B, Bhagat H, Salunke P, Bishnoi S. Comparison of Dexmedetomidine Versus Midazolam-Fentanyl Combination for Monitored Anesthesia Care During Burr-Hole Surgery for Chronic Subdural Hematoma. J Neurosurg Anesthesiol. 2016 Apr;28(2):141-6. doi: 10.1097/ANA.0000000000000194.
PubMed 26018670Sato M, Shirakami G, Fukuda K. Comparison of general anesthesia and monitored anesthesia care in patients undergoing breast cancer surgery using a combination of ultrasound-guided thoracic paravertebral block and local infiltration anesthesia: a retrospective study. J Anesth. 2016 Apr;30(2):244-51. doi: 10.1007/s00540-015-2111-z. Epub 2015 Dec 10.
PubMed 26661141Drown MB. Integrative review utilizing dexmedetomidine as an anesthetic for monitored anesthesia care and regional anesthesia. Nurs Forum. 2011 Jul-Sep;46(3):186-94. doi: 10.1111/j.1744-6198.2011.00229.x.
PubMed 21806629David H, Shipp J. A randomized controlled trial of ketamine/propofol versus propofol alone for emergency department procedural sedation. Ann Emerg Med. 2011 May;57(5):435-41. doi: 10.1016/j.annemergmed.2010.11.025. Epub 2011 Jan 21.
PubMed 21256626Wang W, Feng L, Bai F, Zhang Z, Zhao Y, Ren C. The Safety and Efficacy of Dexmedetomidine vs. Sufentanil in Monitored Anesthesia Care during Burr-Hole Surgery for Chronic Subdural Hematoma: A Retrospective Clinical Trial. Front Pharmacol. 2016 Nov 3;7:410. doi: 10.3389/fphar.2016.00410. eCollection 2016.
PubMed 27857689Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.
PubMed 19378524Cizmeci P, Ozkose Z. Magnesium sulphate as an adjuvant to total intravenous anesthesia in septorhinoplasty: a randomized controlled study. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):167-73. doi: 10.1007/s00266-006-0194-5.
PubMed 17437152Prontera A, Baroni S, Marudi A, Valzania F, Feletti A, Benuzzi F, Bertellini E, Pavesi G. Awake craniotomy anesthetic management using dexmedetomidine, propofol, and remifentanil. Drug Des Devel Ther. 2017 Mar 3;11:593-598. doi: 10.2147/DDDT.S124736. eCollection 2017.
PubMed 28424537
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol Xylocaine Combination for Conscious Sedation During Chronic Subdural Haematoma Surgery. Comparative Study
- ClinicalTrials.gov ID
- NCT03548493
- Acronym / sponsor ID
- CSDH / N-28-2018
- Conditions
- Conscious Sedation
- Keywords
- Magnesium sulphate, Fentanyl, Conscious sedation, chronic subdural haematoma, Propofol, Burr hole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 7 Jun 2018 (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 investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.
Detailed description
Following institutional ethical committee approval, 34 patients undergoing burr-hole surgery for chronic subdural hemorrhage were included in this prospective, randomized, double-blind study.
Written informed consent were obtained from all subjects before enrollment in the study.
During the preanesthetic checkup,the operative procedure and anesthetic techniques were explained to all patients.
Upon arrival to operating theater, standard monitoring were applied to all patients and bispectral index was applied before starting the drug infusions and was used for maintenance of sedation during operation.
Subjects were randomized into 2 groups. Magnesium (M) group received Magnesium sulphate 50mg/kg IV over 15 minutes Followed by continuous infusion at 15 mg/kg/h Fentanyl (F) group received fentanyl 1 μg /kg IV bolus over 15 minutes Followed by continuous infusion starting at 0.5 μg /kg/h Loading and infusion doses of magnesium sulphate and loading doses of fentanyl were chosen from previous studies.
In both groups fentanyl and magnesium sulphate were accompanied by IV propofol at a dose of 50- 150 μg /kg/min bolus over 10 minutes to achieve target sedation level, that is, Ramsay sedation scale (RSS) 3, if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol were given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80 After achieving predefined target sedation level (RSS of 3), surgeons infiltrated the sites of the burrholes with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline infiltrated locally at least 5 minutes before surgical incision. After burr-hole craniotomy followed by the hematoma evacuation is accomplished, the Infusion of sedatives were discontinued just after placement of the final skin suture.
Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head were recorded. The first intervention is to attempt patient reassurance for 30 seconds. If movement continues then the bolus dose of propofol of 0.5 mg/kg was given and infusion dose was increased in the previously described manner till the maximum dose to regain BIS sedation score between 60-80.
If the patient starts to move again the same sequence was repeated. Induction of general anesthesia was deemed the final intervention in case satisfactory condition was not achieved within the rescue propofol.
All patients were transferred to the post-anesthesia care unit (PACU) after surgery.
The data collected are:
- Total amount of Propofol consumption.
- Total number of patient movements
- The intraoperative and postoperative hemodynamic data
- VAS (Visual analogue scale for pain) score
- Time to first rescue analgesic
- Adverse events
- Surgeon satisfaction score was recorded.
Statistical analysis:
Data was analyzed using SPSS © Statistics version 23 (IBM© Corp., Armonk, NY, USA). Chi-square test (Fisher's exact test) was used to examine the relation between qualitative variables. For quantitative data, comparison between the two groups was done using independent sample t-test or Mann-Whitney test as appropriate. All tests were two-tailed. A p-value < 0.05 was considered significant.
Sample Size calculation:
A previous study reported that pre-procedure magnesium sulphate reduced the total propofol requirements to 130±19.09 mg compared to 172.8±29.09 mg with pre-procedure fentanyl. Based on these results, a sample size of 15 cases in each group was satisfactory to elicit the difference at an alpha level of 0.05 and a power of the test of 95%. The sample size was increased to 17 per group to compensate for possible dropouts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 34 patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: 1. Group A (n=17) will receive magnesium sulphate adjuvant to propofol for sedation. 2. Group B (n=17) will receive fentanyl adjuvant to propofol for sedation
| Arm | Type | Receives |
|---|---|---|
| Magnesium (M) group | Experimental | Drug: Magnesium sulphate, Drug: PropofolMagnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation |
| Fentanyl (F) group | Active comparator | Drug: Fentanyl, Drug: PropofolFentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 50 years
- ASA (American Society of Anesthesiologists physical status) grade I to II
- Glasgow coma scale 14-15
- Unilateral chronic subdural hematoma
Key exclusion criteria (9 listed)
- Hypertension (diastolic blood pressure > 160 mmHg)
- Bradycardia (<50 bpm)
- Ischemic heart disease (<6 months)
- Second- or third-degree heart block
- Long-term abuse of or addiction to alcohol, tobacco, 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 sulphateMagnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h | Drug | Magnesium (M) group |
| FentanylFentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h | Drug | Fentanyl (F) group |
| PropofolIn both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80% | Drug | Fentanyl (F) group, Magnesium (M) group |
Primary outcome
Total amount of Propofol consumption in each group
Time frame: From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery
To measure total amount of propofol consumption from induction of conscious sedation till the end of the operation and to compare it between both groups
6 secondary outcomes
To measure the total number of intraoperative patient's movements
Time frame: From the start of the surgery and throughout the duration of the surgery
Heart rate
Time frame: Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
Non invasive blood pressure
Time frame: Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
To assess surgeon satisfaction score
Time frame: 30 minutes after the end of the surgery
VAS score for pain
Time frame: at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.
Time to first rescue analgesic
Time frame: During the 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 4 Dec 2018.
- Background: PubMed 18642135Guzel A, Kaya S, Ozkan U, Ufuk Aluclu M, Ceviz A, Belen D. Surgical treatment of chronic subdural haematoma under monitored anaesthesia care. Swiss Med Wkly. 2008 Jul 12;138(27-28):398-403. doi: 10.4414/smw.2008.12121.
- Background: PubMed 26018670Bishnoi V, Kumar B, Bhagat H, Salunke P, Bishnoi S. Comparison of Dexmedetomidine Versus Midazolam-Fentanyl Combination for Monitored Anesthesia Care During Burr-Hole Surgery for Chronic Subdural Hematoma. J Neurosurg Anesthesiol. 2016 Apr;28(2):141-6. doi: 10.1097/ANA.0000000000000194.
- Background: PubMed 26661141Sato M, Shirakami G, Fukuda K. Comparison of general anesthesia and monitored anesthesia care in patients undergoing breast cancer surgery using a combination of ultrasound-guided thoracic paravertebral block and local infiltration anesthesia: a retrospective study. J Anesth. 2016 Apr;30(2):244-51. doi: 10.1007/s00540-015-2111-z. Epub 2015 Dec 10.
- Background: PubMed 21806629Drown MB. Integrative review utilizing dexmedetomidine as an anesthetic for monitored anesthesia care and regional anesthesia. Nurs Forum. 2011 Jul-Sep;46(3):186-94. doi: 10.1111/j.1744-6198.2011.00229.x.
- Background: PubMed 21256626David H, Shipp J. A randomized controlled trial of ketamine/propofol versus propofol alone for emergency department procedural sedation. Ann Emerg Med. 2011 May;57(5):435-41. doi: 10.1016/j.annemergmed.2010.11.025. Epub 2011 Jan 21.
- Background: PubMed 27857689Wang W, Feng L, Bai F, Zhang Z, Zhao Y, Ren C. The Safety and Efficacy of Dexmedetomidine vs. Sufentanil in Monitored Anesthesia Care during Burr-Hole Surgery for Chronic Subdural Hematoma: A Retrospective Clinical Trial. Front Pharmacol. 2016 Nov 3;7:410. doi: 10.3389/fphar.2016.00410. eCollection 2016.
- Background: PubMed 19378524Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.
- Background: PubMed 17437152Cizmeci P, Ozkose Z. Magnesium sulphate as an adjuvant to total intravenous anesthesia in septorhinoplasty: a randomized controlled study. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):167-73. doi: 10.1007/s00266-006-0194-5.
- Background: PubMed 28424537Prontera A, Baroni S, Marudi A, Valzania F, Feletti A, Benuzzi F, Bertellini E, Pavesi G. Awake craniotomy anesthetic management using dexmedetomidine, propofol, and remifentanil. Drug Des Devel Ther. 2017 Mar 3;11:593-598. doi: 10.2147/DDDT.S124736. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Conscious Sedation, 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 9 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 4 Dec 2018. 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?
Total amount of Propofol consumption in each group (time frame: From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery). 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 NCT03548493, which also lists 9 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 4 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.