TimeNCT07165483
Do Increasing Preoperative Timing of Single Dexmedetomidine Dose Have an Effect on Stress Response of Laryngoscopy and Intubation?
A study testing Dexmedetomidine and Saline in people with Time and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of increasing preoperative timing of single dexmedetomidine on the stress response of laryngoscopy and intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Time, Dexmedetomidine, Stress Response
- What is being tested?
- Dexmedetomidine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2025to 1 Mar 2026
- 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 Anesthesiology (ASA) physical status I-II.
Who cannot join
- Severe cardiovascular problems.
- Respiratory disorders.
- Diabetes.
- Hypertension.
- Obesity.
- Allergic reaction to study drugs.
Show all 12Show fewer
- Patients on antihypertensive medication (α-methyldopa, clonidine, or other α2-adrenergic agonists)
- Medications that affect heart rate (HR) or blood pressure (BP).
- Pregnant.
- Currently breast-feeding women.
- History of sleep apnea.
- Those for emergency procedures.
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
Tanta University
Tanta, El-Gharbia, 31527
Mohammed S Elsharkawy, MD, 00201148207870, mselsharkawy@med.tanta.edu.eg
Saad A Moharam, MD
About this study
Official title: Do Increasing Preoperative Timing of Single Dexmedetomidine Dose Have an Effect on Stress Response of Laryngoscopy and Intubation? A Randomized Controlled Trial
This study aims to evaluate the effect of increasing preoperative timing of single dexmedetomidine on the stress response of laryngoscopy and intubation.
Read the detailed description
Maintaining hemodynamic stability during surgery is one of the most important tasks because good anesthesia increases the success rate of surgery and improves postoperative prognosis.
Dexmedetomidine, a potent α2-adrenoreceptor agonist, produces not only a sedative-hypnotic effect, but in situations involving cardiac risk, it also produces analgesic effects and an autonomic blocking effect, by acting on a single type of receptor.
- Conditions
- Time, Dexmedetomidine, Stress Response, Laryngoscopy, Intubation
- Being tested
- Dexmedetomidine, Saline
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia.
DexmedetomidineDrug
Patients will receive saline (over 10 min) 20 min before induction of anesthesia then 0.5µg/kg dexmedetomidine (over 10 min) 10 min before induction of anesthesia.
SalineDrug
Patients will receive saline before induction of anesthesia as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Group D20 | Experimental | Patients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia. Receives: Drug: Dexmedetomidine |
| Group D10 | Experimental | Patients will receive saline (over 10 min) 20 min before induction of anesthesia then 0.5µg/kg dexmedetomidine (over 10 min) 10 min before induction of anesthesia. Receives: Drug: Dexmedetomidine |
| Group C | Placebo comparator | Patients will receive saline before induction of anesthesia as a control group. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Mean arterial pressure will be recorded at baseline, before induction, after induction, before intubation, after intubation, at 5 minutes, 10 minutes, 15 minutes, and then every 15 minutes until the end of surgery.
Measured: Till the end of the surgery (Up to 2 hours)
Secondary outcomes (3)
Heart rate
Heart rate will be recorded at baseline, before induction, after induction, before intubation, after intubation, at 5 minutes, 10 minutes, 15 minutes, and then every 15 minutes until the end of surgery.
Measured: Till the end of the surgery (Up to 2 hours)
Need for intraoperative fentanyl
Need for intraoperative fentanyl will be recorded.
Measured: Intraoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, 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 posted10 Sep 2025
- Study start11 Sep 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TimeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165483
- Sponsor's protocol ID
- 36264PR1334/8/25
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 12 Sep 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Increasing Preoperative Timing of Single Dexmedetomidine Dose Have an Effect on Stress Response of Laryngoscopy and Intubation? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07165483
- Acronym / sponsor ID
- 36264PR1334/8/25
- Conditions
- Time, Dexmedetomidine, Stress Response, Laryngoscopy, Intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 Sep 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.
This study aims to evaluate the effect of increasing preoperative timing of single dexmedetomidine on the stress response of laryngoscopy and intubation.
Detailed description
Maintaining hemodynamic stability during surgery is one of the most important tasks because good anesthesia increases the success rate of surgery and improves postoperative prognosis.
Dexmedetomidine, a potent α2-adrenoreceptor agonist, produces not only a sedative-hypnotic effect, but in situations involving cardiac risk, it also produces analgesic effects and an autonomic blocking effect, by acting on a single type of receptor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D20 | Experimental | Drug: DexmedetomidinePatients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia. |
| Group D10 | Experimental | Drug: DexmedetomidinePatients will receive saline (over 10 min) 20 min before induction of anesthesia then 0.5µg/kg dexmedetomidine (over 10 min) 10 min before induction of anesthesia. |
| Group C | Placebo comparator | Drug: SalinePatients will receive saline before induction of anesthesia 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 (3 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
Key exclusion criteria (12 listed)
- Severe cardiovascular problems.
- Respiratory disorders.
- Diabetes.
- Hypertension.
- Obesity.
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 |
|---|---|---|
| DexmedetomidinePatients will receive 0.5µg/kg dexmedetomidine (over 10 min) 20 min before induction of anesthesia then saline (over 10 min) 10 min before induction of anesthesia. | Drug | Group D20 |
| DexmedetomidinePatients will receive saline (over 10 min) 20 min before induction of anesthesia then 0.5µg/kg dexmedetomidine (over 10 min) 10 min before induction of anesthesia. | Drug | Group D10 |
| SalinePatients will receive saline before induction of anesthesia as a control group. | Drug | Group C |
Primary outcome
Mean arterial pressure
Time frame: Till the end of the surgery (Up to 2 hours)
Mean arterial pressure will be recorded at baseline, before induction, after induction, before intubation, after intubation, at 5 minutes, 10 minutes, 15 minutes, and then every 15 minutes until the end of surgery.
3 secondary outcomes
Heart rate
Time frame: Till the end of the surgery (Up to 2 hours)
Need for intraoperative fentanyl
Time frame: Intraoperatively
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 12 Sep 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 Dexmedetomidine and Saline in people with Time and Dexmedetomidine, run by Tanta 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 3 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: looking for participants now, as of the sponsor's last update on 12 Sep 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 Mohammed S Elsharkawy, MD (00201148207870, mselsharkawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: Till the end of the surgery (Up to 2 hours)). 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 12 Sep 2025.