Hemodynamic InstabilityPhase 4NCT05909215
Attenuation Of Hemodynamic Response To Laryngoscopy. Role Of Dexmedetomidine. A Dose Finding Study
A Phase 4 study testing Normal saline, Dexmedetomidine 0.5 microgram/kg and Dexmedetomidine 0.75 microgram/kg in people with Hemodynamic Instability and Tracheal Intubation, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress response to laryngoscopy in American Society of Anesthesiology, physical class I patients which will be compared with the placebo-controlled group. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Tracheal Intubation, Dexmedetomidine
- What is being tested?
- Normal saline, Dexmedetomidine 0.5 microgram/kg and Dexmedetomidine 0.75 microgram/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Aug 2021to 13 Dec 2021
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 55 years
- ASA I or II patients undergoing surgery under general anaesthesia with endotracheal intubation.
- Patients with Mallampati class I or II.
Who cannot join
- ASA III \& IV patients
- Anticipated or unanticipated difficult intubations which requires more than 15 seconds or more than one attempt.
- Patients with Mallampati class III, IV or with loose teeth.
- Patients with inotropes infusion.
- Patients with known allergy to any anaesthetic agents
- Patients with a heart rate of 60 beats/min or less
- Patients with known hypertension, incidental finding of hypertension while on operating table, diabetes, ischemic heart disease or peripheral vascular disease.
- Pregnant and lactating mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress response to laryngoscopy in American Society of Anesthesiology, physical class I patients which will be compared with the placebo-controlled group.
Read the detailed description
A randomized, double-blind controlled trial will be conducted to determine the attenuation of stress response caused by laryngoscopy and tracheal intubation (LTI). After the Institutional Ethics Committee approval, (Sindh Institute of Urology and Transplantation, Pakistan), written informed consent will be obtained from 105 adult patients.
Randomization will be done using a computer-generated random number table. Patients will be divided into three groups. Group A "Placebo group", will receive 20 mL of normal saline (NS), Group B "dexmedetomidine 0.5", will receive dexmedetomidine 0.5 μ/kg, whereas, Group C "dexmedetomidine 0.75", will receive dexmedetomidine 0.75 μ/kg, all as a 20mL infusion through a syringe pump over 10 minutes followed by induction of general anesthesia.
No premedication will be given in the ward. Once the patients will arrive in the operating room, routine monitoring (electrocardiogram, pulse oximetry, non-invasive blood pressure) will be started. After recording the baseline vitals and Ramsay sedation score, the study drug or normal saline (according to randomization) will be given in a look-alike syringe over 10 minutes. The study drug will be prepared as a 20 mL solution in a 25 mL syringe. An independent co-investigator (anaesthesiologist) who will not be involved in administering general anesthesia or recording the study parameters will prepare the study drug(s) according to the body weight or NS using identical-looking syringes. Study drug infusion will be started once the patient is taken to the operating table. Vitals and sedation scores will be recorded at 0,1,3,5 and 10 minutes during infusion. Investigators will keep the atropine drawn in a syringe and ready to be given in case of heart rate goes below 40 beats/min. Ephedrine (5mg/ml) and adrenaline 10µ/ml will also be ready for use.
Once completing the infusion, general anesthesia will be administered using a standard protocol (Nalbuphine 0.15 mg/kg, Propofol 2.5 mg/kg, Atracurium 0.6 mg/kg after assessing easy bag-mask ventilation in all patients. After 3-minute bag-mask ventilation with Isoflurane at 1.5% in 100% oxygen, the trachea will be intubated by one of three senior anaesthesiologists involved in this study. The intubating duration will be kept below 15 seconds. Hemodynamic monitoring will be continued for another 10 minutes at 1, 3, 5 and 10 minutes after intubating the trachea.
- Being tested
- Normal saline, Dexmedetomidine 0.5 microgram/kg, Dexmedetomidine 0.75 microgram/kg
- Keywords
- Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Mean Arterial Pressure, Precedex, Tracheal Intubation, Laryngoscopy, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called Placebo group
Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes
Dexmedetomidine 0.5 microgram/kgDrug
Dexmedetomidine 0.5 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Dexmedetomidine 0.75 microgram/kgDrug
Dexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.5 | Active comparator | Dexmedetomidine 0.5 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia. Receives: Drug: Normal saline; Drug: Dexmedetomidine 0.5 microgram/kg |
| Dexmedetomidine 0.75 | Active comparator | Dexmedetomidine 0.75 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia. Receives: Drug: Normal saline; Drug: Dexmedetomidine 0.75 microgram/kg |
| Placebo | Placebo comparator | 20 mL of normal saline as an infusion through a syringe pump over 10 minutes followed by induction of general anesthesia. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Response
Mean change in the heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be assessed.
Measured: 0 to 10 minutes after endotracheal intubation
Secondary outcomes (1)
Adverse events
Adverse events after intervention such as drowsiness, nausea, vomiting, or severe bradycardia will be observed.
Measured: 0 to 30 minutes from the start of infusion to 10 minutes after endotracheal intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start23 Aug 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation
- Investigators
- Syed M Abbas, Principal investigator, Associate Professor Dept of Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909215
- Sponsor's protocol ID
- SindhInstitute
- Status last verified
- Jun 2023
- First submitted
- 7 Feb 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation Of Hemodynamic Response To Laryngoscopy. Role Of Dexmedetomidine. A Dose Finding Study
- ClinicalTrials.gov ID
- NCT05909215
- Acronym / sponsor ID
- SindhInstitute
- Keywords
- Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Mean Arterial Pressure, Precedex, Tracheal Intubation, Laryngoscopy, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 18 Jun 2023 (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.
Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress response to laryngoscopy in American Society of Anesthesiology, physical class I patients which will be compared with the placebo-controlled group.
Detailed description
A randomized, double-blind controlled trial will be conducted to determine the attenuation of stress response caused by laryngoscopy and tracheal intubation (LTI). After the Institutional Ethics Committee approval, (Sindh Institute of Urology and Transplantation, Pakistan), written informed consent will be obtained from 105 adult patients.
Randomization will be done using a computer-generated random number table. Patients will be divided into three groups. Group A "Placebo group", will receive 20 mL of normal saline (NS), Group B "dexmedetomidine 0.5", will receive dexmedetomidine 0.5 μ/kg, whereas, Group C "dexmedetomidine 0.75", will receive dexmedetomidine 0.75 μ/kg, all as a 20mL infusion through a syringe pump over 10 minutes followed by induction of general anesthesia.
No premedication will be given in the ward. Once the patients will arrive in the operating room, routine monitoring (electrocardiogram, pulse oximetry, non-invasive blood pressure) will be started. After recording the baseline vitals and Ramsay sedation score, the study drug or normal saline (according to randomization) will be given in a look-alike syringe over 10 minutes. The study drug will be prepared as a 20 mL solution in a 25 mL syringe. An independent co-investigator (anaesthesiologist) who will not be involved in administering general anesthesia or recording the study parameters will prepare the study drug(s) according to the body weight or NS using identical-looking syringes. Study drug infusion will be started once the patient is taken to the operating table. Vitals and sedation scores will be recorded at 0,1,3,5 and 10 minutes during infusion. Investigators will keep the atropine drawn in a syringe and ready to be given in case of heart rate goes below 40 beats/min. Ephedrine (5mg/ml) and adrenaline 10µ/ml will also be ready for use.
Once completing the infusion, general anesthesia will be administered using a standard protocol (Nalbuphine 0.15 mg/kg, Propofol 2.5 mg/kg, Atracurium 0.6 mg/kg after assessing easy bag-mask ventilation in all patients. After 3-minute bag-mask ventilation with Isoflurane at 1.5% in 100% oxygen, the trachea will be intubated by one of three senior anaesthesiologists involved in this study. The intubating duration will be kept below 15 seconds. Hemodynamic monitoring will be continued for another 10 minutes at 1, 3, 5 and 10 minutes after intubating the trachea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.5 | Active comparator | Drug: Normal saline, Drug: Dexmedetomidine 0.5 microgram/kgDexmedetomidine 0.5 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia. |
| Dexmedetomidine 0.75 | Active comparator | Drug: Normal saline, Drug: Dexmedetomidine 0.75 microgram/kgDexmedetomidine 0.75 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia. |
| Placebo | Placebo comparator | Drug: Normal saline20 mL of normal saline as an infusion through a syringe pump over 10 minutes followed by induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 to 55 years
- ASA I or II patients undergoing surgery under general anaesthesia with endotracheal intubation.
- Patients with Mallampati class I or II.
Key exclusion criteria (8 listed)
- ASA III \& IV patients
- Anticipated or unanticipated difficult intubations which requires more than 15 seconds or more than one attempt.
- Patients with Mallampati class III, IV or with loose teeth.
- Patients with inotropes infusion.
- Patients with known allergy to any anaesthetic agents
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 |
|---|---|---|
| Normal salineAlso: Placebo groupNormal saline 20mL will be given intravenously through a syringe pump over 10 minutes | Drug | Dexmedetomidine 0.5, Dexmedetomidine 0.75, Placebo |
| Dexmedetomidine 0.5 microgram/kgDexmedetomidine 0.5 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes | Drug | Dexmedetomidine 0.5 |
| Dexmedetomidine 0.75 microgram/kgDexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes | Drug | Dexmedetomidine 0.75 |
Primary outcome
Hemodynamic Response
Time frame: 0 to 10 minutes after endotracheal intubation
Mean change in the heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be assessed.
1 secondary outcome
Adverse events
Time frame: 0 to 30 minutes from the start of infusion to 10 minutes after endotracheal intubation)
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 18 Jun 2023.
- 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.
Syed M Abbas principal investigator
Associate Professor Dept of Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal saline, Dexmedetomidine 0.5 microgram/kg and Dexmedetomidine 0.75 microgram/kg in people with Hemodynamic Instability and Tracheal Intubation, run by Sindh Institute of Urology and Transplantation 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 3 inclusion and 8 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 18 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hemodynamic Response (time frame: 0 to 10 minutes after endotracheal 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 18 Jun 2023.