Intraoperative AwarenessPhase 4NCT04086940
Role of Intraoperative Beta Blocker for Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery
A Phase 4 study testing Esmolol in people with Intraoperative Awareness and Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Intraoperative Awareness, Postoperative Pain
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2019to Dec 2019
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I - II patients
- age between 18-59 years
- both genders
- body mass index (BMI) > 45 kg/m2
Who cannot join
- Patients with -hepatic
- renal
- cardiac
- respiratory diseases
- patients with a history of drug abuse or who were dependent on opioid drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer of Anesthesia
Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.
Read the detailed description
Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.
Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.
- Conditions
- Intraoperative Awareness, Postoperative Pain
- Being tested
- Esmolol
- Keywords
- role, INTRAOPERATIVE, beta blocker, bariatric surgery, morbid obese
- Medical subject headings
- Intraoperative Awareness, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called normal saline
preventive
| Study group | Role | What they receive |
|---|---|---|
| esmolol(breviblock) group | Active comparator | Patients in group E received a loading dose of esmolol(breviblock) 1 mg/kg in 50 ml isotonic saline over 30 minutes before induction of anesthesia, then followed by an infusion of esmolol 10 µg/kg/min until the end of the surgery. Receives: Drug: Esmolol |
| non esmolol group | Active comparator | Patients in group N received 50 ml of isotonic saline over 30 min, followed by an infusion of isotonic saline at same rate of group E till the end of the surgery. Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative analgesic requirements
amount of narcotics and anesthetics needed
Measured: 6 months
postoperative analgesic requirements
amount of narcotics needed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative AwarenessStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086940
- Sponsor's protocol ID
- Ain Shams university 1
- Status last verified
- Nov 2019
- First submitted
- 5 Sep 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Anesthesia
- ClinicalTrials.gov ID
- NCT04086940
- Acronym / sponsor ID
- Ain Shams university 1
- Conditions
- Intraoperative Awareness, Postoperative Pain
- Keywords
- role, INTRAOPERATIVE, beta blocker, bariatric surgery, morbid obese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Sep 2019 (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.
Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.
Detailed description
Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.
Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| esmolol(breviblock) group | Active comparator | Drug: EsmololPatients in group E received a loading dose of esmolol(breviblock) 1 mg/kg in 50 ml isotonic saline over 30 minutes before induction of anesthesia, then followed by an infusion of esmolol 10 µg/kg/min until the end of the surgery. |
| non esmolol group | Active comparator | Drug: EsmololPatients in group N received 50 ml of isotonic saline over 30 min, followed by an infusion of isotonic saline at same rate of group E till the end of the surgery. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I - II patients
- age between 18-59 years
- both genders
- body mass index (BMI) > 45 kg/m2
Key exclusion criteria (5 listed)
- Patients with -hepatic
- renal
- cardiac
- respiratory diseases
- patients with a history of drug abuse or who were dependent on opioid drugs.
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 |
|---|---|---|
| EsmololAlso: normal salinepreventive | Drug | esmolol(breviblock) group, non esmolol group |
Primary outcome
intraoperative analgesic requirements
Time frame: 6 months
amount of narcotics and anesthetics needed
postoperative analgesic requirements
Time frame: 6 months
amount of narcotics needed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Individual participant dataSharing planned: No. after publication
Related trials for Intraoperative Awareness
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Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
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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 Phase 4 study testing Esmolol in people with Intraoperative Awareness and Postoperative Pain, run by Ain Shams 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. 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.
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?
Results are not available in the source record.
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?
intraoperative analgesic requirements (time frame: 6 months). The study lists 2 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 25 Nov 2019.