IntraoperativeNCT06966518
Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty
A study testing Ketamine and Magnesium Sulfate and Saline 0.9% in people with Intraoperative and Ketamine, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraoperative, Ketamine, Magnesium Sulfate
- What is being tested?
- Ketamine and Magnesium Sulfate and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I - II.
- Scheduled for rhinoplasty under general anesthesia.
Who cannot join
- Receiving analgesic or any medications since 48 hours before the surgery.
- Drug addiction.
- Cardiovascular disease.
- Respiratory disease, renal, liver, metabolic and neurological disease.
- Pregnancy or breast feeding.
- Asthma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Sarah A Afifi, MD, 0501035864, Sarah606060@gmail.com
Maram I Elmazny, MD
About this study
Official title: Effectiveness of Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Patients Undergoing Open Rhinoplasty: A Randomized Controlled Trial
The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.
Read the detailed description
Postoperative pain remains one of the most crucial factors affecting patient satisfaction. These symptoms can be distressing for the patient and it may lead to negative psychological implications.
Ketamine is a non-competitive N-Methyl D-Aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nervous systems.
Magnesium sulfate is also an antagonist for NMDA receptor that has been evaluated in several studies and showed that Mg sulfate decreased consumption of postoperative opioids.
Ketamine and magnesium sulfate have different sites of action on NMDA receptors, so their combination may produce a synergistic effect on NMDA receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.
- Being tested
- Ketamine and Magnesium Sulfate, Saline 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine and Magnesium SulfateDrug
Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr.
Saline 0.9%Drug
Patients will receive saline 0.9% as a control group.
| Study group | Role | What they receive |
|---|---|---|
| KM Group | Experimental | Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr. Receives: Drug: Ketamine and Magnesium Sulfate |
| Control group | Placebo comparator | Patients will receive saline 0.9% as a control group. Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as a 3 mg bolus if the numeric rating scale (NRS) > 3, to be repeated after 30 min if pain persists until the NRS < 4.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Time to the 1st rescue analgesia.
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 6, 8, 12, 18, and 24 h postoperatively.
Measured: 24 hours postoperatively
Heart rate
Heart rate will be recorded preoperatively and every 15 minutes till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively and every 15 minutes till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours postoperatively
Incidence of adverse events.
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hallucinations, nightmares, blurred vision, dizziness or any other complication.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2025
- Study start12 May 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntraoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966518
- Sponsor's protocol ID
- 36264PR1199/4/25
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Patients Undergoing Open Rhinoplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06966518
- Acronym / sponsor ID
- 36264PR1199/4/25
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 May 2025 (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 study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.
Detailed description
Postoperative pain remains one of the most crucial factors affecting patient satisfaction. These symptoms can be distressing for the patient and it may lead to negative psychological implications.
Ketamine is a non-competitive N-Methyl D-Aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nervous systems.
Magnesium sulfate is also an antagonist for NMDA receptor that has been evaluated in several studies and showed that Mg sulfate decreased consumption of postoperative opioids.
Ketamine and magnesium sulfate have different sites of action on NMDA receptors, so their combination may produce a synergistic effect on NMDA receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KM Group | Experimental | Drug: Ketamine and Magnesium SulfatePatients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr. |
| Control group | Placebo comparator | Drug: Saline 0.9%Patients will receive saline 0.9% as a control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I - II.
- Scheduled for rhinoplasty under general anesthesia.
Key exclusion criteria (6 listed)
- Receiving analgesic or any medications since 48 hours before the surgery.
- Drug addiction.
- Cardiovascular disease.
- Respiratory disease, renal, liver, metabolic and neurological disease.
- Pregnancy or breast feeding.
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 |
|---|---|---|
| Ketamine and Magnesium SulfatePatients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr. | Drug | KM Group |
| Saline 0.9%Patients will receive saline 0.9% as a control group. | Drug | Control group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as a 3 mg bolus if the numeric rating scale (NRS) > 3, to be repeated after 30 min if pain persists until the NRS < 4.
6 secondary outcomes
Time to the 1st rescue analgesia.
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Mean arterial pressure
Time frame: Till the end of surgery (Up to 2 hours)
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events.
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Magnesium Sulfate and Saline 0.9% in people with Intraoperative and Ketamine, run by Ain Shams University 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 6 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah A Afifi, MD (0501035864, Sarah606060@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours postoperatively). 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 13 May 2025.