AnesthesiaNCT03818048
Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy
A study testing Propofol and Sevoflurane in people with Anesthesia, run by Centro Medico Docente la Trinidad.
Trial summary
To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy. A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 28 Dec 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
- patients who are going to undergo diagnostic colonoscopies
- patients who signed the informed consent
Who cannot join
- Allergy or hypersensitivity to some of the reference drugs in the study
- patients with proven liver disease
- suspicion or confirmation of pregnancy
- antecedent or risk of malignant hyperthermia
- fasting less than 8 hours
- patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
- patients who have acute illnesses that compromise their health for which the study cannot be performed
About this study
Official title: Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy
To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.
A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
- Conditions
- Anesthesia
- Being tested
- Propofol, Sevoflurane
- Keywords
- sedation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)
SevofluraneDrug
after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
| Study group | Role | What they receive |
|---|---|---|
| Group Propofol | Experimental | propofol infusion Receives: Drug: Propofol |
| Group Sevoflurane | Experimental | inhalation with sevoflurane Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
heart rate per minute
Measured: During the colonoscopy - an estimated mean time of 20 minutes
The Recovery Time
Every 5 minutes till a score of 10/10 achieved on Aldrete Score
Measured: 30 min
Propofol dosage
propofol rescate bolus administered
Measured: During the colonoscopy - an estimated mean time of 20 minutes
arterial pressure
non invasive arterial pressure every 5 minutes
Measured: During the colonoscopy - an estimated mean time of 20 minutes
oxygen saturation
pulse oximetry
Measured: During the colonoscopy - an estimated mean time of 20 minutes
Secondary outcomes (3)
adverse reactions in patients
desaturation, laryngospasm
Measured: 1 day (postoperative)
Endoscopist Satisfaction
Endoscopist Satisfaction scored from 1-10. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied)
Measured: 60 min
Qualitatively assess patient comfort after sedation.
poor, regular or good
Measured: Up to 1 hour after completing the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Jan 2016
- Primary completion1 Oct 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Docente la Trinidad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leopoldo Wulff, Centro Medico Docente la Trinidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818048
- Sponsor's protocol ID
- CMDLT
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2019
- Last updated
- 28 Jan 2019
- 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 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy
- ClinicalTrials.gov ID
- NCT03818048
- Acronym / sponsor ID
- CMDLT
- Conditions
- Anesthesia
- Keywords
- sedation, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centro Medico Docente la TrinidadUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 28 Jan 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.
To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.
A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Propofol | Experimental | Drug: Propofolpropofol infusion |
| Group Sevoflurane | Experimental | Drug: Sevofluraneinhalation with sevoflurane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
- patients who are going to undergo diagnostic colonoscopies
- patients who signed the informed consent
Key exclusion criteria (7 listed)
- Allergy or hypersensitivity to some of the reference drugs in the study
- patients with proven liver disease
- suspicion or confirmation of pregnancy
- antecedent or risk of malignant hyperthermia
- fasting less than 8 hours
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 |
|---|---|---|
| Propofolafter inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min) | Drug | Group Propofol |
| Sevofluraneafter inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow. | Drug | Group Sevoflurane |
Primary outcome
Heart rate
Time frame: During the colonoscopy - an estimated mean time of 20 minutes
heart rate per minute
The Recovery Time
Time frame: 30 min
Every 5 minutes till a score of 10/10 achieved on Aldrete Score
Propofol dosage
Time frame: During the colonoscopy - an estimated mean time of 20 minutes
propofol rescate bolus administered
arterial pressure
Time frame: During the colonoscopy - an estimated mean time of 20 minutes
non invasive arterial pressure every 5 minutes
oxygen saturation
Time frame: During the colonoscopy - an estimated mean time of 20 minutes
pulse oximetry
3 secondary outcomes
adverse reactions in patients
Time frame: 1 day (postoperative)
Endoscopist Satisfaction
Time frame: 60 min
Qualitatively assess patient comfort after sedation.
Time frame: Up to 1 hour after completing the study.
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 28 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Anesthesia, run by Centro Medico Docente la Trinidad.
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 7 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 28 Jan 2019. 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.
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?
Heart rate (time frame: During the colonoscopy - an estimated mean time of 20 minutes). The study lists 5 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 28 Jan 2019.