HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATIONTHENCT07596004
COMPARISON OF DEXMEDETOMIDINE AND NORMAL SALINE IN NEBULIZATION TO BLUNT HEMODYNAMIC RESPONSE
A study testing Dexmeditomidine and Normal Saline (0.9% Sodium Chloride) in people with HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
BLUNTING OF HEMODYNAMIC RESPONSE WILL BE OBSERVED IN PATIENTS NEBULISED WITH DEXMEDETOMIDINE AND NORMAL SALINE. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION
- What is being tested?
- Dexmeditomidine and Normal Saline (0.9% Sodium Chloride)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2026to 30 Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Either gender
- ASA Physical Status I and II
- Mallampati airway class I and II
- BMI 18-30 kg/m2
- Patients undergoing elective surgery under general anesthesia
Who cannot join
- Patient refusal or lack of consent
- Anticipated difficult airway
- Intubation attempt lasting more than 15 seconds
- Pregnancy
- Uncontrolled hypertension, cardiac, pulmonary, hepatic, or cerebral events
- Known allergy to dexmedetomidine or study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Nebulised Dexmedetomidine Versus Nebulised Saline Preoperatively To Attenuate Hemodynamic Response to Laryngoscopy and Endotracheal Intubation: A Randomised Control Trial
BLUNTING OF HEMODYNAMIC RESPONSE WILL BE OBSERVED IN PATIENTS NEBULISED WITH DEXMEDETOMIDINE AND NORMAL SALINE.
Read the detailed description
ONE GROUP OF PTS WILL BE NEBULISED WITH DEXMEDETOMIDINE AND OTHER WITH NORMAL SALINE AND WILL BE OBSERVED DURING AND AFTER INTUBATION FOR ATTENUATION OF HEMODYNAMIC RESPONSE FOR LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION
- Being tested
- Dexmeditomidine, Normal Saline (0.9% Sodium Chloride)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmeditomidineDrug
dexmeditomidine 1mcg/kg diluted in 5ml 0.9% sodium chloride, administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction .
Normal Saline (0.9% Sodium Chloride)Drug
normal saline 5 ml administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| nebulised dexmedetomidine | Experimental | participants will receive nebulised dexmedetomidine 1 microgram/kg diluted in 5ml normal saline via nebulised over 5 minutes, administered 30 minutes before induction of anesthesia. standard monitoring of hemodynamic parameters will be done at baseline, 1 minute and 3 minutes post-intubation Receives: Drug: Dexmeditomidine |
| nebulised saline | Placebo comparator | participants will receive nebulised 5ml normal saline via nebulised over 5 minutes, administered 30 minutes before induction of anesthesia. standard monitoring of hemodynamic parameters will be done at baseline, 1 minute and 3 minutes post-intubation. Receives: Drug: Normal Saline (0.9% Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean artirial pressure and heart rate after lyrangoscopy and intubation
hemodynamic stress response measured as change in mean arterial pressure and heart rate from baseline. MAP and HR will be recorded at baseline T0, 1 minute post intubation T1 ans 3 minute post intubation T3. Significant stress response is defined as rise in MAP nad HR more than 10% of baseline at 3 minutes post intubation.
Measured: baseline, 1 minute and 3 minute post intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start10 Mar 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATIONStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: Group A received nebulised dexmedetomidine 1 mcg/kg, and Group B received nebulised normal saline 5 ml. Both groups received intervention 30 minutes before induction of anesthesia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BATOOL ZEHRA, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596004
- Sponsor's protocol ID
- BZEHRA
- Other IDs
- SMBBIT
- Acronym
- THE
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect participant confidentiality and privacy as per institutional ethics committee guidelines and informed consent obtained from participants. Data may be shared upon reasonable request to the principal investigator, subject to approval by the institutional ethics committee and execution of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nebulised Dexmedetomidine Versus Nebulised Saline Preoperatively To Attenuate Hemodynamic Response to Laryngoscopy and Endotracheal Intubation: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07596004
- Acronym / sponsor ID
- THE / BZEHRA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 May 2026 (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.
BLUNTING OF HEMODYNAMIC RESPONSE WILL BE OBSERVED IN PATIENTS NEBULISED WITH DEXMEDETOMIDINE AND NORMAL SALINE.
Detailed description
ONE GROUP OF PTS WILL BE NEBULISED WITH DEXMEDETOMIDINE AND OTHER WITH NORMAL SALINE AND WILL BE OBSERVED DURING AND AFTER INTUBATION FOR ATTENUATION OF HEMODYNAMIC RESPONSE FOR LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: Group A received nebulised dexmedetomidine 1 mcg/kg, and Group B received nebulised normal saline 5 ml. Both groups received intervention 30 minutes before induction of anesthesia.
| Arm | Type | Receives |
|---|---|---|
| nebulised dexmedetomidine | Experimental | Drug: Dexmeditomidineparticipants will receive nebulised dexmedetomidine 1 microgram/kg diluted in 5ml normal saline via nebulised over 5 minutes, administered 30 minutes before induction of anesthesia. standard monitoring of hemodynamic parameters will be done at baseline, 1 minute and 3 minutes post-intubation |
| nebulised saline | Placebo comparator | Drug: Normal Saline (0.9% Sodium Chloride)participants will receive nebulised 5ml normal saline via nebulised over 5 minutes, administered 30 minutes before induction of anesthesia. standard monitoring of hemodynamic parameters will be done at baseline, 1 minute and 3 minutes post-intubation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years
- Either gender
- ASA Physical Status I and II
- Mallampati airway class I and II
- BMI 18-30 kg/m2
Key exclusion criteria (6 listed)
- Patient refusal or lack of consent
- Anticipated difficult airway
- Intubation attempt lasting more than 15 seconds
- Pregnancy
- Uncontrolled hypertension, cardiac, pulmonary, hepatic, or cerebral events
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 |
|---|---|---|
| Dexmeditomidinedexmeditomidine 1mcg/kg diluted in 5ml 0.9% sodium chloride, administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction . | Drug | nebulised dexmedetomidine |
| Normal Saline (0.9% Sodium Chloride)normal saline 5 ml administered via nebulizer over 5 minutes, 30 minutes prior to anesthetic induction. | Drug | nebulised saline |
Primary outcome
change in mean artirial pressure and heart rate after lyrangoscopy and intubation
Time frame: baseline, 1 minute and 3 minute post intubation
hemodynamic stress response measured as change in mean arterial pressure and heart rate from baseline. MAP and HR will be recorded at baseline T0, 1 minute post intubation T1 ans 3 minute post intubation T3. Significant stress response is defined as rise in MAP nad HR more than 10% of baseline at 3 minutes post intubation.
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 19 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect participant confidentiality and privacy as per institutional ethics committee guidelines and informed consent obtained from participants. Data may be shared upon reasonable request to the principal investigator, subject to approval by the institutional ethics committee and execution of a data sharing agreement.
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 study testing Dexmeditomidine and Normal Saline (0.9% Sodium Chloride) in people with HEMODYNAMIC RESPONSETO LYRANGOSCOPY AND ENDOTRACHEAL INTUBATION, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. 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 Pakistan. 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?
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?
change in mean artirial pressure and heart rate after lyrangoscopy and intubation (time frame: baseline, 1 minute and 3 minute post intubation). 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 19 May 2026.