HypertensionEarly Phase 1NCT04646317
Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy
A Early Phase 1 study testing Dexmedetomidine injection and Normal Saline in people with Hypertension and Laparoscopic Cholecystectomy, run by Dr. Ruth K.M. Pfau Civil Hospital, Karachi at 1 site in Pakistan.
Trial summary
Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Hypertension, Laparoscopic Cholecystectomy
- What is being tested?
- Dexmedetomidine injection and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2020to 2 Mar 2021
- Phase
- Early Phase 1
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hypertensive patients of both genders of age 17 years to 70 years who are undergoing laparoscopic cholecystectomy.
- ASA II and III
Who cannot join
- Patients with a prior history of cardiac disease like ischemic heart disease, valvular disorders, undergone previous valve replacements, infective endocarditis and rheumatic fever.
- Renal diseases like acute kidney injury and chronic renal diseases.
- Endocrinal diseases like pheochromocytoma, hyperthyroidism, hypothyroidism, cushing disease etc.
- Pregnant and lactating females
- Short thick neck with anticipated difficult intubation
- Any sort of obstructive restrictive or reactive airway disease
Show all 9Show fewer
- Patient allergic to any of the study medications.
- Obese patients (BMI>35)
- Narcotic addicts
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences
Karachi, Sindh, 75520
Muhammad Imran, FCPS, +923342947181, dr.imranriasat@gmail.com
Hanya Javaid, FCPS, +923452424442, drhanyajavaidi@gmail.com
About this study
Official title: To Observe the Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy.
Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic surgeries form an essence of today's surgical practice because of its magnification, less cosmetic scar, less postoperative pain, and decreased hospital stay along with less morbidity and mortality.
According to the American Heart Association (AHA), approximately 86 million adults (34%) in the United States are affected by hypertension, which is defined as a systolic blood pressure (SBP) of 140 mm Hg or more or a diastolic blood pressure (DBP) of 90 mm Hg or more, taking anti-hypertensive medication of those with high blood pressure (BP), 78% were aware they were hypertensive, 68% were being treated with anti-hypertensive agents, and only 64% of treated individuals had controlled hypertension.
Anaesthetic management in these patients has become complicated due to cardiopulmonary changes occurring during creation of pneumoperitoneum with CO2 and patient position required for different laparoscopy surgeries. Effects of pneumoperitoneum for laparoscopic surgeries on heart rate and blood pressure was recognized more than 50years ago and the magnitude of the changes was observed to depend on the depth of anesthesia. The cardiovascular, neuroendocrine, and renal changes induced by the CO2 pneumoperitoneum produce a complex pathophysiological state remarkably similar to that in patients with chronic heart failure, though the initiating event is clearly very different. In normotensive subjects these hemodynamic changes are short lived5and probably of little significance. However, these haemodynamic alterations are hazardous to the patients with hypertension, myocardial insufficiency or cerebrovascular disease.
Various pharmacologic and nonpharmacological methods have been tried to limit the pressor response following the creation of pneumoperitoneum. The success rate is variable with different methods because each method has its own merits and demerits. In several clinical trials drugs like opioids, β-blockers, lidocaine, nitrate calcium channel blockers or magnesium have already been used orally or parenterally to obtund this sympathoadrenal response. Recently, there is considerable interest in the use of α2-adrenergic agonists to provide hemodynamic stability during pneumoperitoneum.
Dexmedetomidine famous for its awake sedation is eight times more selective than clonidine for the α2-adrenergic receptors. The ratio of α2:α1 activity of dexmedetomidine is 1620:1. It activates pro-survival kinases and attenuates ischemia and hypoxic injury, including cardio protection. Concurrent infusion during surgery reduces anesthetic consumption by 20-50% , and produces a decrease in heart rate and blood pressure that may be advantageous for hypertensives. Hypertension associated to pneumoperitoneum in normotensive patients has been controlled with the loading dose of dexmedetomidine. So our rational is to see the hemodynamic stability of dexmedatomindine in hypertensive patients undergoing pneumoperitoneum.
- Conditions
- Hypertension, Laparoscopic Cholecystectomy
- Being tested
- Dexmedetomidine injection, Normal Saline
- Keywords
- Attenuation, dexmedetomidine, pneumoperitoneum, hemodynamic stability, pressor response, laryngoscopy response, intubation response
- Medical subject headings
- Hypertension, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Also called dexmedetomidine
Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.
Normal SalineDrug
0.9% as placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine Receives: Drug: Dexmedetomidine injection |
| normaL SALINE 0.9% | Placebo comparator | Four 50 ml syringes of .9 % Normal SALINE Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic blood pressure during pneumoperitoneum
Systolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Measured: From baseline to the end of pneumoperitonium, an average of 2 hours
change in Diastolic blood pressure during pneumoperitoneum
Diastolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Measured: from baseline to the end of pneumoperitoneum, an average of 2 hours
change in Mean Arterial blood pressure during pneumoperitoneum
Mean Arterial blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Measured: from baseline to the end of pneumoperitoneum, an average of 2 hours
change in Heart Rate during pneumoperitoneum
Heart rate will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Measured: from baseline to the end of pneumoperitoneum, an average of 2 hours
Secondary outcomes (7)
Systolic blood pressure intubation
SBP will be noted at the induction.
Measured: Induction
Diastolic Blood pressure intubation
DBP will be noted at the induction
Measured: Induction
Mean Arterial blood pressure intubation
MAP will be noted at the induction.
Measured: Induction
heart rate intubation
HR will be noted at the induction.
Measured: Induction
Post operative sedation
Modified Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response From completion of surgery to 30 minutes post operatively
Measured: every 5 minutes, up to 30minutes
Post operative analgesia
Visual analogue scale From completion of surgery to 30 minutes post operatively (0 no pain, 10 wost pain)
Measured: every 5 minutes, up to 30minutes
Complication
bradycardia, tachycardia, hypertension and hypotension
Measured: every 5 minutes from induction, up to 30 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start30 Dec 2020 (estimated)
- Primary completion2 Mar 2021 (estimated)
- Study completion2 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Ruth K.M. Pfau Civil Hospital, Karachi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Imran Riasat, Dr. Ruth K.M. Pfau Civil Hospital, Karachi
- Investigators
- Muhammad Imran, FCPS, Principal investigator, Dow University of Health SciencesHanya Javaid, FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646317
- Sponsor's protocol ID
- PfauCHKarachi
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Observe the Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT04646317
- Acronym / sponsor ID
- PfauCHKarachi
- Conditions
- Hypertension, Laparoscopic Cholecystectomy
- Keywords
- Attenuation, dexmedetomidine, pneumoperitoneum, hemodynamic stability, pressor response, laryngoscopy response, intubation response
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Dr. Ruth K.M. Pfau Civil Hospital, KarachiOther government
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 2 Mar 2021 (estimated)
- First posted
- 27 Nov 2020 (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.
Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy.
Detailed description
Laparoscopic surgeries form an essence of today's surgical practice because of its magnification, less cosmetic scar, less postoperative pain, and decreased hospital stay along with less morbidity and mortality.
According to the American Heart Association (AHA), approximately 86 million adults (34%) in the United States are affected by hypertension, which is defined as a systolic blood pressure (SBP) of 140 mm Hg or more or a diastolic blood pressure (DBP) of 90 mm Hg or more, taking anti-hypertensive medication of those with high blood pressure (BP), 78% were aware they were hypertensive, 68% were being treated with anti-hypertensive agents, and only 64% of treated individuals had controlled hypertension.
Anaesthetic management in these patients has become complicated due to cardiopulmonary changes occurring during creation of pneumoperitoneum with CO2 and patient position required for different laparoscopy surgeries. Effects of pneumoperitoneum for laparoscopic surgeries on heart rate and blood pressure was recognized more than 50years ago and the magnitude of the changes was observed to depend on the depth of anesthesia. The cardiovascular, neuroendocrine, and renal changes induced by the CO2 pneumoperitoneum produce a complex pathophysiological state remarkably similar to that in patients with chronic heart failure, though the initiating event is clearly very different. In normotensive subjects these hemodynamic changes are short lived5and probably of little significance. However, these haemodynamic alterations are hazardous to the patients with hypertension, myocardial insufficiency or cerebrovascular disease.
Various pharmacologic and nonpharmacological methods have been tried to limit the pressor response following the creation of pneumoperitoneum. The success rate is variable with different methods because each method has its own merits and demerits. In several clinical trials drugs like opioids, β-blockers, lidocaine, nitrate calcium channel blockers or magnesium have already been used orally or parenterally to obtund this sympathoadrenal response. Recently, there is considerable interest in the use of α2-adrenergic agonists to provide hemodynamic stability during pneumoperitoneum.
Dexmedetomidine famous for its awake sedation is eight times more selective than clonidine for the α2-adrenergic receptors. The ratio of α2:α1 activity of dexmedetomidine is 1620:1. It activates pro-survival kinases and attenuates ischemia and hypoxic injury, including cardio protection. Concurrent infusion during surgery reduces anesthetic consumption by 20-50% , and produces a decrease in heart rate and blood pressure that may be advantageous for hypertensives. Hypertension associated to pneumoperitoneum in normotensive patients has been controlled with the loading dose of dexmedetomidine. So our rational is to see the hemodynamic stability of dexmedatomindine in hypertensive patients undergoing pneumoperitoneum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine injectionDexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine |
| normaL SALINE 0.9% | Placebo comparator | Drug: Normal SalineFour 50 ml syringes of .9 % Normal SALINE |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertensive patients of both genders of age 17 years to 70 years who are undergoing laparoscopic cholecystectomy.
- ASA II and III
Key exclusion criteria (9 listed)
- Patients with a prior history of cardiac disease like ischemic heart disease, valvular disorders, undergone previous valve replacements, infective endocarditis and rheumatic fever.
- Renal diseases like acute kidney injury and chronic renal diseases.
- Endocrinal diseases like pheochromocytoma, hyperthyroidism, hypothyroidism, cushing disease etc.
- Pregnant and lactating females
- Short thick neck with anticipated difficult intubation
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 |
|---|---|---|
| Dexmedetomidine injectionAlso: dexmedetomidineInfusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre. | Drug | Dexmedetomidine |
| Normal Saline0.9% as placebo | Drug | normaL SALINE 0.9% |
Primary outcome
Change in Systolic blood pressure during pneumoperitoneum
Time frame: From baseline to the end of pneumoperitonium, an average of 2 hours
Systolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
change in Diastolic blood pressure during pneumoperitoneum
Time frame: from baseline to the end of pneumoperitoneum, an average of 2 hours
Diastolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
change in Mean Arterial blood pressure during pneumoperitoneum
Time frame: from baseline to the end of pneumoperitoneum, an average of 2 hours
Mean Arterial blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
change in Heart Rate during pneumoperitoneum
Time frame: from baseline to the end of pneumoperitoneum, an average of 2 hours
Heart rate will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
7 secondary outcomes
Systolic blood pressure intubation
Time frame: Induction
Diastolic Blood pressure intubation
Time frame: Induction
Mean Arterial blood pressure intubation
Time frame: Induction
heart rate intubation
Time frame: Induction
Post operative sedation
Time frame: every 5 minutes, up to 30minutes
Post operative analgesia
Time frame: every 5 minutes, up to 30minutes
Complication
Time frame: every 5 minutes from induction, up to 30 minutes post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- 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.
Muhammad Imran, FCPS principal investigator
Dow University of Health Sciences
Hanya Javaid, FCPS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine injection and Normal Saline in people with Hypertension and Laparoscopic Cholecystectomy, run by Dr. Ruth K.M. Pfau Civil Hospital, Karachi 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Imran, FCPS (+923342947181, dr.imranriasat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic blood pressure during pneumoperitoneum (time frame: From baseline to the end of pneumoperitonium, an average of 2 hours). The study lists 4 primary outcomes in all. 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 22 Dec 2020.