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HypertensionNCT07258628

Comparison of Fentanyl and Magnesium to Control Reflex Hemodynamics in Patients Aged 50 and Older

A study testing magnesium sulfate and Fentanyl (IV) in people with Hypertension and Tachycardia, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, randomized, controlled trial aims to evaluate the effects of magnesium sulfate and fentanyl on the hemodynamic response to endotracheal intubation in surgical patients aged 50 years and older. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Hypertension, Tachycardia
What is being tested?
magnesium sulfate and Fentanyl (IV)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesTurkey (Türkiye)
Study dates
10 Oct 2025to 30 Jan 2026
Phase
Interventional
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

  • Age ≥ 50 years
  • Patients scheduled for elective surgery under general anesthesia
  • Patients requiring endotracheal intubation with a single-lumen tube
  • Provision of written informed consent

Who cannot join

  • Known renal or hepatic insufficiency
  • Thyroid dysfunction
  • Uncontrolled hypertension
  • Suspected difficult airway (Mallampati ≥ 3 or history of difficult intubation)
  • Known allergy or hypersensitivity to study medications
  • Myocardial infarction within the past 3 months
Show all 12Show fewer
  • Presence of heart block
  • Preoperative hypermagnesemia
  • Withdrawal Criteria:
  • Laryngoscopy time exceeding 20 seconds
  • Withdrawal of informed consent
  • Patient withdrawal from the study at any time

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

    Ankara, Ankara, 06800

  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Magnesium and Fentanyl in Preventing Reflex Hemodynamic Response to Endotracheal Intubation in Patients Aged 50 Years and Older

This prospective, randomized, controlled trial aims to evaluate the effects of magnesium sulfate and fentanyl on the hemodynamic response to endotracheal intubation in surgical patients aged 50 years and older. A total of 75 patients will be enrolled and randomized into three groups: magnesium sulfate alone, magnesium sulfate plus fentanyl, and fentanyl alone. The primary outcome measures are changes in mean arterial pressure (MAP) and heart rate before and after intubation. Secondary outcomes include BIS, SEF, ST, TOF recovery times, intraoperative hemodynamic stability, and perioperative complications.

Read the detailed description

Endotracheal intubation can trigger significant hemodynamic changes, such as tachycardia and hypertension, due to sympathetic activation. These responses are particularly detrimental in older patients with cardiovascular comorbidities, increasing the risk of perioperative morbidity and mortality.

The aim of this study is to compare the effectiveness of magnesium sulfate and fentanyl, administered alone or in combination, in attenuating the hemodynamic response to intubation in patients aged 50 years and older undergoing elective surgery.

This is a single-center, prospective, randomized, controlled trial. A total of 75 patients will be randomized into three groups:

Group M: Magnesium sulfate 30 mg/kg IV infusion over 10 minutes Group X: Magnesium sulfate 30 mg/kg IV infusion over 10 minutes plus fentanyl 2 mcg/kg IV Group F: Fentanyl 2 mcg/kg IV Standardized anesthesia induction and monitoring will be performed. The primary outcome measures are mean arterial pressure (MAP) and heart rate, recorded at baseline, post-induction, and at 1, 3, 5, 10, and 15 minutes after intubation. Secondary outcomes include BIS, SEF, and ST values; TOF recovery times; anesthesia duration; intraoperative blood loss; fluids and blood products administered; and perioperative complications.

The findings of this study are expected to provide valuable insights into the pharmacological management of intubation-induced hemodynamic responses in the elderly surgical population.

Being tested
magnesium sulfate, Fentanyl (IV)
Keywords
Hemodynamic response, Elderly patients / age 50 and older, Magnesium sulfate, Fentanyl, Endotracheal intubation, Tachycardia, Hypertension
Medical subject headings
Hypertension, Tachycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • magnesium sulfateDrug

    Also called MgSO₄, Epsom Salt, Magnesium Sulphate 15% Solution

    Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes

  • Fentanyl (IV)Drug

    Also called Fentanyl Citrate, Sublimaze, Talinat, Fentanyl Injection

    Fentanyl 2 mcg/kg administered intravenously as a bolus

Study groups in NCT07258628
Study groupRoleWhat they receive
Magnesium Sulfate Infusion Group (30 mg/kg)ExperimentalArm M: Magnesium sulfate (30 mg/kg IV over 10 min)
Receives: Drug: magnesium sulfate
Fentanyl Only Group (2 mcg/kg)ExperimentalParticipants will receive fentanyl 2 mcg/kg intravenously as a bolus
Receives: Drug: Fentanyl (IV)
Combined Magnesium Sulfate (30 mg/kg) and Fentanyl (2 mcg/kg) GroupExperimentalParticipants will receive magnesium sulfate 30 mg/kg intravenously over 10 minutes combined with fentanyl 2 mcg/kg intravenously
Receives: Drug: magnesium sulfate; Drug: Fentanyl (IV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Arterial Pressure (MAP) Changes

    Change in mean arterial pressure (MAP) to assess the hemodynamic response to endotracheal intubation. MAP will be measured at baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.

    Measured: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.

  2. 1. Heart Rate (HR) Changes

    Change in heart rate to assess the hemodynamic response to endotracheal intubation. Heart rate will be measured at baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.

    Measured: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.

Secondary outcomes (2)

  1. Train of Four (TOF) Recovery Time

    Time required for early neuromuscular recovery following administration of rocuronium. Continuous neuromuscular monitoring will be performed, and the duration from rocuronium injection until return of TOF count to 2 will be recorded.

    Measured: Intraoperatively when TOF count reaches 2.

  2. Perioperative Complications

    Incidence of perioperative complications, including hypotension, hypertension, bradycardia, tachycardia, and arrhythmia, recorded during the first 15 minutes after endotracheal intubation.

    Measured: From immediately after endotracheal intubation up to 15 minutes post-intubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start10 Oct 2025
  3. Primary completion10 Jan 2026
  4. Study completion30 Jan 2026

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center, three-arm, randomized, parallel-group interventional trial. Participants are assigned in a 1:1:1 ratio via sealed opaque envelopes to receive MgSO₄ 30 mg/kg IV over 10 minutes, MgSO₄ 30 mg/kg IV over 10 minutes plus fentanyl 2 mcg/kg IV, or fentanyl 2 mcg/kg IV. Masking: single-blind (outcome assessor/statistician); treating anesthesiologist is open-label. Standardized induction is performed with BIS and TOF monitoring; cases with laryngoscopy time \>20 seconds are excluded. Primary endpoints are MAP and heart rate changes at baseline, post-intubation, and at 1-15 minutes after intubation.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258628
Sponsor's protocol ID
TABED 1-25-1089
Status last verified
Sep 2025
First submitted
19 Sep 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Misganaw A, Sitote M, Jemal S, Melese E, Hune M, Seyoum F, Sema A, Bimrew D. Comparison of intravenous magnesium sulphate and lidocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in elective surgical patients at Zewditu Memorial Hospital Addis Ababa, Ethiopia. PLoS One. 2021 Jun 1;16(6):e0252465. doi: 10.1371/journal.pone.0252465. eCollection 2021.

    PubMed 34061894

  • Aissaoui Y, Qamous Y, Serghini I, Zoubir M, Salim JL, Boughalem M. Magnesium sulphate: an adjuvant to tracheal intubation without muscle relaxation--a randomised study. Eur J Anaesthesiol. 2012 Aug;29(8):391-7. doi: 10.1097/EJA.0b013e328355cf35.

    PubMed 22717726

  • James MF, Beer RE, Esser JD. Intravenous magnesium sulfate inhibits catecholamine release associated with tracheal intubation. Anesth Analg. 1989 Jun;68(6):772-6.

    PubMed 2735543

Questions about this trial

What is this clinical trial studying?

A study testing magnesium sulfate and Fentanyl (IV) in people with Hypertension and Tachycardia, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).

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 12 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). 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.

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?

Mean Arterial Pressure (MAP) Changes (time frame: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.). The study lists 2 primary outcomes in all. 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 NCT07258628, 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 19 Mar 2026.

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