AnesthesiaNCT04284644
Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques
A study testing Induction using propofol, Induction using sevoflurane and Induction using propofol and sevoflurane in people with Anesthesia and Anesthesia; Adverse Effect, run by University of Jordan at 1 site in Jordan.
Trial summary
Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia; Adverse Effect
- What is being tested?
- Induction using propofol, Induction using sevoflurane and Induction using propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2016to 3 Jan 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- patients with Age ≥ 65 years.
- American Society of Anaesthesiologists' (ASA) score II or III.
- minimally invasive endoscopic urological procedures.
Who cannot join
- patient refusal.
- Age < 65 years.
- family history of malignant hyperthermia.
- prolonged surgery that needed intubation.
- body mass index (BMI) > 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study
Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction.
Read the detailed description
Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. This technique is considered an approach that can be of a great benefit to patients with chronic medical illnesses and those who have moderate to high risk for general anaesthesia.
In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction. The investigators evaluated the time needed for laryngeal mask airway (LMA) insertion, number of LMA insertion trials, succession of LMA insertion, adverse events related to the airway, respiratory and cardiovascular systems, haemodynamic stability and satisfaction scores of enrolled patients.
- Conditions
- Anesthesia, Anesthesia; Adverse Effect
- Being tested
- Induction using propofol, Induction using sevoflurane, Induction using propofol and sevoflurane
- Keywords
- General anesthesia, Propofol, Sevoflurane, Co-induction, Laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction using propofolDrug
Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, a dose of 1.5 mg/kg of propofol slowly over 2 minutes.
Induction using sevofluraneDrug
Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 8% inhalational sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen.
Induction using propofol and sevofluraneDrug
Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 4% sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | Patient received a dose of 1.5 mg/kg of Propofol slowly over 2 minutes for induction. Receives: Drug: Induction using propofol |
| Group S | Experimental | Patient received 8% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen. Receives: Drug: Induction using sevoflurane |
| Group C | Experimental | Patient received 4% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly. Receives: Drug: Induction using propofol and sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative respiratory adverse events
The investigators recorded the occurrence of transient apnea intraoperatively, in addition to laryngeal spasm, coughing, gagging and increased salivation. The study chart included the documentation these common adverse events, the timing of occurrence, and the intervention required to manage these events.
Measured: 8 months
Secondary outcomes (4)
Time for successful laryngeal mask airway insertion
The investigators assessed the time needed for LMA insertion. The timer was started upon giving the fentanyl, recording the time till successful insertion of laryngeal mask airway.
Measured: 8 months
Blood pressure stability
The investigators recorded patients' blood pressure readings throughout the induction procedure.
Measured: 8 months
Heart rate stability
The investigators recorded patients' heart rate throughout the induction procedure.
Measured: 8 months
Changes in oxygen saturation
The investigators recorded patients' oxygen saturation throughout the induction procedure.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 May 2016
- Primary completion2 Jan 2017
- Study completion3 Jan 2017
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omar ahmad ababneh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284644
- Sponsor's protocol ID
- 10/2016/4597
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- 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 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT04284644
- Acronym / sponsor ID
- 10/2016/4597
- Conditions
- Anesthesia, Anesthesia; Adverse Effect
- Keywords
- General anesthesia, Propofol, Sevoflurane, Co-induction, Laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 26 Feb 2020 (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.
Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction.
Detailed description
Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. This technique is considered an approach that can be of a great benefit to patients with chronic medical illnesses and those who have moderate to high risk for general anaesthesia.
In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction. The investigators evaluated the time needed for laryngeal mask airway (LMA) insertion, number of LMA insertion trials, succession of LMA insertion, adverse events related to the airway, respiratory and cardiovascular systems, haemodynamic stability and satisfaction scores of enrolled patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Drug: Induction using propofolPatient received a dose of 1.5 mg/kg of Propofol slowly over 2 minutes for induction. |
| Group S | Experimental | Drug: Induction using sevofluranePatient received 8% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen. |
| Group C | Experimental | Drug: Induction using propofol and sevofluranePatient received 4% sevoflurane through sealed plastic facemask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patients with Age ≥ 65 years.
- American Society of Anaesthesiologists' (ASA) score II or III.
- minimally invasive endoscopic urological procedures.
Key exclusion criteria (5 listed)
- patient refusal.
- Age < 65 years.
- family history of malignant hyperthermia.
- prolonged surgery that needed intubation.
- body mass index (BMI) > 35 kg/m2.
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 |
|---|---|---|
| Induction using propofolPatients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, a dose of 1.5 mg/kg of propofol slowly over 2 minutes. | Drug | Group P |
| Induction using sevofluranePatients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 8% inhalational sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen. | Drug | Group S |
| Induction using propofol and sevofluranePatients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 4% sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly. | Drug | Group C |
Primary outcome
Intraoperative respiratory adverse events
Time frame: 8 months
The investigators recorded the occurrence of transient apnea intraoperatively, in addition to laryngeal spasm, coughing, gagging and increased salivation. The study chart included the documentation these common adverse events, the timing of occurrence, and the intervention required to manage these events.
4 secondary outcomes
Time for successful laryngeal mask airway insertion
Time frame: 8 months
Blood pressure stability
Time frame: 8 months
Heart rate stability
Time frame: 8 months
Changes in oxygen saturation
Time frame: 8 months
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 26 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
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
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
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 Induction using propofol, Induction using sevoflurane and Induction using propofol and sevoflurane in people with Anesthesia and Anesthesia; Adverse Effect, run by University of Jordan at 1 site in Jordan.
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: finished, as of the sponsor's last update on 26 Feb 2020. 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 Jordan. 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?
Intraoperative respiratory adverse events (time frame: 8 months). 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 26 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.