Anesthesia EmergencePhase 2NCT03219788
Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries
A Phase 2 study testing Normal Saline, Remifentanil 0.1 ug/kg and Remifentanil 0.2 ug/kg in people with Anesthesia Emergence, run by Assiut University.
Trial summary
The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia Emergence
- What is being tested?
- Normal Saline, Remifentanil 0.1 ug/kg and Remifentanil 0.2 ug/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2017to 1 Nov 2017
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 years
- Subject has signed informed consent for bariatric laparoscopic surgery.
- Subject must be ASA I or ASA II according to the American Society of Anesthetists classification.
Who cannot join
- Age < 18 years.
- Smoking patient.
- Hypertension.
- Bronchial asthma.
- Obstructive sleep apnea syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study
The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.
Read the detailed description
The investigators designed this study to examine the effect of different small doses of Remifentanil on the incidence of cough reflex during emergence from anesthesia in obese patients undergoing bariatric surgery. The investigators will study if these small doses will delay the recovery of the patient or not. The other expected side effects will be observed eg. Respiratory depression. Time to the first painkiller required will be registered
- Conditions
- Anesthesia Emergence
- Being tested
- Normal Saline, Remifentanil 0.1 ug/kg, Remifentanil 0.2 ug/kg
- Keywords
- emergence, remifentanil, recovery, desflurene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called Placebo
All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given
Remifentanil 0.1 ug/kgDrug
All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given
Remifentanil 0.2 ug/kgDrug
All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given
| Study group | Role | What they receive |
|---|---|---|
| Group 1(Normal saline) | Placebo comparator | Patients who will receive placebo (one ml normal saline). The drug will be given after closure of desflurane at an exhaled MAC of 0.3. Receives: Drug: Normal Saline |
| Group 2 (Remifentanil 0.1 ug/kg) | Active comparator | Patients who will receive remifentanil at a dose of 0.1 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3. Receives: Drug: Remifentanil 0.1 ug/kg |
| Group 3 ((Remifentanil 0.2 ug/kg)) | Active comparator | Patients who will receive remifentanil at a dose of 0.2 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3. Receives: Drug: Remifentanil 0.2 ug/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemodynamic
Mean blood pressure and heart rate will be recorded before surgery and combined with all the other study items at the end of surgery, at the extubation time, after 5 minutes in PACU, after 10 minutes in Postanesthesia Care Unit (PACU) and he last registered reading in PACU.
Measured: within the first 24 hours
antitussive effect
cough assessment at recovery time 0 no cough
- single cough
- cough episode less than five seconds or multiple coughs
- sustained attack of cough lasts more than five seconds
Measured: within the first 24 hours
Secondary outcomes (2)
Respiratory depression
In the postoperative period
Measured: within the first 24 hours
Postoperative pain
The duration from extubation till the first painkiller and pain severity using VAS at the extubation time will recorded
Measured: within the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start20 Jul 2017 (estimated)
- Primary completion1 Nov 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia EmergenceStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mohamed Shaaban Ali, PhD, MD, Assiut University
- Investigators
- Mohamed S Ali, MD, Principal investigator, Associate profossor of anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219788
- Sponsor's protocol ID
- IRB00008715892
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT03219788
- Acronym / sponsor ID
- IRB00008715892
- Conditions
- Anesthesia Emergence
- Keywords
- emergence, remifentanil, recovery, desflurene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2017 (estimated)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 18 Jul 2017 (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.
The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.
Detailed description
The investigators designed this study to examine the effect of different small doses of Remifentanil on the incidence of cough reflex during emergence from anesthesia in obese patients undergoing bariatric surgery. The investigators will study if these small doses will delay the recovery of the patient or not. The other expected side effects will be observed eg. Respiratory depression. Time to the first painkiller required will be registered
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1(Normal saline) | Placebo comparator | Drug: Normal SalinePatients who will receive placebo (one ml normal saline). The drug will be given after closure of desflurane at an exhaled MAC of 0.3. |
| Group 2 (Remifentanil 0.1 ug/kg) | Active comparator | Drug: Remifentanil 0.1 ug/kgPatients who will receive remifentanil at a dose of 0.1 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3. |
| Group 3 ((Remifentanil 0.2 ug/kg)) | Active comparator | Drug: Remifentanil 0.2 ug/kgPatients who will receive remifentanil at a dose of 0.2 ug/kg. The drug will be given after closure of desflurane at an exhaled MAC of 0.3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥ 18 years
- Subject has signed informed consent for bariatric laparoscopic surgery.
- Subject must be ASA I or ASA II according to the American Society of Anesthetists classification.
Key exclusion criteria (5 listed)
- Age < 18 years.
- Smoking patient.
- Hypertension.
- Bronchial asthma.
- Obstructive sleep apnea syndrome.
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: PlaceboAll the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given | Drug | Group 1(Normal saline) |
| Remifentanil 0.1 ug/kgAll the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given | Drug | Group 2 (Remifentanil 0.1 ug/kg) |
| Remifentanil 0.2 ug/kgAll the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given | Drug | Group 3 ((Remifentanil 0.2 ug/kg)) |
Primary outcome
Changes in hemodynamic
Time frame: within the first 24 hours
Mean blood pressure and heart rate will be recorded before surgery and combined with all the other study items at the end of surgery, at the extubation time, after 5 minutes in PACU, after 10 minutes in Postanesthesia Care Unit (PACU) and he last registered reading in PACU.
antitussive effect
Time frame: within the first 24 hours
cough assessment at recovery time 0 no cough 1. single cough 2. cough episode less than five seconds or multiple coughs 3. sustained attack of cough lasts more than five seconds
2 secondary outcomes
Respiratory depression
Time frame: within the first 24 hours
Postoperative pain
Time frame: within the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
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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.
Mohamed S Ali, MD principal investigator
Associate profossor of anesthesiology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal Saline, Remifentanil 0.1 ug/kg and Remifentanil 0.2 ug/kg in people with Anesthesia Emergence, run by Assiut University.
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 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mohamed S Ali, MD (0020882413201, msali58@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hemodynamic (time frame: within the first 24 hours). 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 18 Jul 2017.