DexmedetomidineNCT06052111
Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy
A study testing Group F (fentanyl group) and Group D (dexmedetomidine group) in people with Dexmedetomidine and Fentanyl, run by Helwan University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dexmedetomidine, Fentanyl, Time to Extubation
- What is being tested?
- Group F (fentanyl group) and Group D (dexmedetomidine group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2021to 15 May 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 50 years old.
- Both sexes.
- American Standards Association (ASA) physical status II - III.
- Body Mass Index (BMI) ≥ 35 kg/m2.
Who cannot join
- Allergy to α2 -adrenergic agonist.
- History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
- Neuromuscular disease, liver disease (coagulopathy INR>1.5 or platelet count <100.000/μl), renal impairment (serum creatinine >1.2mg/dl, serum K >5.5mmol/l).
- Opioid medication within 24 hours before the operation.
- Respiratory diseases as COPD, uncontrolled asthmatic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial
This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.
- Conditions
- Dexmedetomidine, Fentanyl, Time to Extubation, Morbid Obesity, Laparoscopic Sleeve Gastrectomy
- Being tested
- Group F (fentanyl group), Group D (dexmedetomidine group)
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group F (fentanyl group)Drug
Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation and was stopped 10 minutes before the end of surgery.
Group D (dexmedetomidine group)Drug
The patients received loading dose of dexmedetomidine (1 μg/kg) (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) intravenously over 15 minutes before induction of anesthesia followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group F (fentanyl group) | Experimental | Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation. It was stopped 10 minutes before the end of surgery. Receives: Drug: Group F (fentanyl group) |
| Group D (dexmedetomidine group) | Experimental | The patients were received a loading dose of dexmedetomidine (1 μg/kg) intravenously over 15 minutes before induction of anesthesia, followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery. Receives: Drug: Group D (dexmedetomidine group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time for extubation
Time from end of anesthesia till safe extubation of the patients
Measured: 30 minutes till end of surgery.
Secondary outcomes (3)
Mean arterial blood pressure (MAP)
Mean arterial blood pressure will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Measured: Intraoperatively.
Heart rate (HR)
Heart rate will be recorded (baseline, after induction, after tracheal intubation, at trochers insertion, during insufflation, at regular intervals throughout the surgery (every 5 minutes) until the end of surgery.
Measured: Intraoperatively
Incidence of hypotension
Mean arterial blood pressure (MAP)<60mmHg. Ephedrine (5 mg) and 250 ml fluid bolus will be given if MAP < 60 mmHg or decrease 20% of the baseline value.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start15 May 2021
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Mohammed Bakr, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052111
- Sponsor's protocol ID
- 26-2020
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial
- ClinicalTrials.gov ID
- NCT06052111
- Acronym / sponsor ID
- 26-2020
- Conditions
- Dexmedetomidine, Fentanyl, Time to Extubation, Morbid Obesity, Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 25 Sep 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.
This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.
Detailed description
The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F (fentanyl group) | Experimental | Drug: Group F (fentanyl group)Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation. It was stopped 10 minutes before the end of surgery. |
| Group D (dexmedetomidine group) | Experimental | Drug: Group D (dexmedetomidine group)The patients were received a loading dose of dexmedetomidine (1 μg/kg) intravenously over 15 minutes before induction of anesthesia, followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 20 to 50 years old.
- Both sexes.
- American Standards Association (ASA) physical status II - III.
- Body Mass Index (BMI) ≥ 35 kg/m2.
Key exclusion criteria (5 listed)
- Allergy to α2 -adrenergic agonist.
- History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
- Neuromuscular disease, liver disease (coagulopathy INR>1.5 or platelet count <100.000/μl), renal impairment (serum creatinine >1.2mg/dl, serum K >5.5mmol/l).
- Opioid medication within 24 hours before the operation.
- Respiratory diseases as COPD, uncontrolled asthmatic patients.
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 |
|---|---|---|
| Group F (fentanyl group)Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation and was stopped 10 minutes before the end of surgery. | Drug | Group F (fentanyl group) |
| Group D (dexmedetomidine group)The patients received loading dose of dexmedetomidine (1 μg/kg) (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) intravenously over 15 minutes before induction of anesthesia followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery. | Drug | Group D (dexmedetomidine group) |
Primary outcome
The time for extubation
Time frame: 30 minutes till end of surgery.
Time from end of anesthesia till safe extubation of the patients
3 secondary outcomes
Mean arterial blood pressure (MAP)
Time frame: Intraoperatively.
Heart rate (HR)
Time frame: Intraoperatively
Incidence of hypotension
Time frame: Intraoperatively
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 25 Sep 2023.
- 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. 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 Group F (fentanyl group) and Group D (dexmedetomidine group) in people with Dexmedetomidine and Fentanyl, run by Helwan 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 4 inclusion and 5 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 25 Sep 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 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. 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?
The time for extubation (time frame: 30 minutes till end of surgery.). 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 25 Sep 2023.