Total Intravenous AnesthesiaPhase 2NCT03727607
TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery
A Phase 2 study testing Desflurane in people with Total Intravenous Anesthesia and Desflurane, run by Ostfold Hospital Trust.
Trial summary
Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Intravenous Anesthesia, Desflurane, Obesity
- What is being tested?
- Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2016to 14 Mar 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥35 kg/m2 with at least one comorbid condition or BMI ≥40 kg/m2.
Who cannot join
- drug abuse
- severe mental illness
- age<18
- serious medical condition; cancer, end-stage lung disease (ASA>3) or allergies to any drugs used in the study
About this study
Official title: A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea
Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery.
The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies which have shown a reduction in postoperative nausea and vomiting following TIVA, and there are publications showing no statistically significant difference.
Read more
The aim of this study was to investigate the best anaesthetic approach for obese subjects, evaluating awakening time, postoperative nausea and pain.
Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and therefore might have a prolonged effect in obese patients, leading to a longer awakening time along with postoperative nausea and vomiting. This hypothesis is also described earlier by obese patients have more depots (bulk fat) and also more fat surface making anaesthetics storage more easier, and also that the anesthetic will return into the circulation when the administration is stopped [18].
- Conditions
- Total Intravenous Anesthesia, Desflurane, Obesity, Pain, Postoperative, Nausea, Postoperative
- Being tested
- Desflurane
- Medical subject headings
- Obesity, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called PROPOFOL
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
| Study group | Role | What they receive |
|---|---|---|
| Gass | Active comparator | DESFLURANE ANESTHESIA Receives: Drug: Desflurane |
| TIVA | Active comparator | TOTAL INTRAVENOUS ANESTHESIA Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awakening time after surgery
time noted from anaesthesia stoped to patients awake
Measured: 2 hours postdose
Degree of nausea and vomiting after surgery
Noted using NRS scale (from 0-10)
Measured: 48 hours postsurgery
Degree of pain after surgery
Noted using NRS scale (from 0-10)
Measured: 48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start30 Jan 2016
- Primary completion11 Dec 2017
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Intravenous AnesthesiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727607
- Sponsor's protocol ID
- 2016/1659
- Status last verified
- Oct 2018
- First submitted
- 14 Mar 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea
- ClinicalTrials.gov ID
- NCT03727607
- Acronym / sponsor ID
- 2016/1659
- Conditions
- Total Intravenous Anesthesia, Desflurane, Obesity, Pain, Postoperative, Nausea, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 1 Nov 2018 (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.
Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery.
The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies which have shown a reduction in postoperative nausea and vomiting following TIVA, and there are publications showing no statistically significant difference.
The aim of this study was to investigate the best anaesthetic approach for obese subjects, evaluating awakening time, postoperative nausea and pain.
Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and therefore might have a prolonged effect in obese patients, leading to a longer awakening time along with postoperative nausea and vomiting. This hypothesis is also described earlier by obese patients have more depots (bulk fat) and also more fat surface making anaesthetics storage more easier, and also that the anesthetic will return into the circulation when the administration is stopped [18].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Gass | Active comparator | Drug: DesfluraneDESFLURANE ANESTHESIA |
| TIVA | Active comparator | Drug: DesfluraneTOTAL INTRAVENOUS ANESTHESIA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥35 kg/m2 with at least one comorbid condition or BMI ≥40 kg/m2.
Key exclusion criteria (4 listed)
- drug abuse
- severe mental illness
- age<18
- serious medical condition; cancer, end-stage lung disease (ASA>3) or allergies to any drugs used in the study
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 |
|---|---|---|
| DesfluraneAlso: PROPOFOLDesflurane vs TIVA, bariatric surgery. Postoperative nausea and pain | Drug | Gass, TIVA |
Primary outcome
Awakening time after surgery
Time frame: 2 hours postdose
time noted from anaesthesia stoped to patients awake
Degree of nausea and vomiting after surgery
Time frame: 48 hours postsurgery
Noted using NRS scale (from 0-10)
Degree of pain after surgery
Time frame: 48 hours post surgery
Noted using NRS scale (from 0-10)
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 1 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Total Intravenous Anesthesia
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Recruiting
Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
Fospropofol Disodium
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desflurane in people with Total Intravenous Anesthesia and Desflurane, run by Ostfold Hospital Trust.
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 1 inclusion and 4 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 1 Nov 2018. 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. 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?
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?
Awakening time after surgery (time frame: 2 hours postdose). The study lists 3 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 1 Nov 2018.