Sedation ComplicationPhase 4NCT05996588
Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP
A Phase 4 study testing Propofol 1 % Injectable Suspension and Sevoflurane in people with Sedation Complication, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
After approval of ethical committee of Sindh Institute of Urology \& Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedation Complication
- What is being tested?
- Propofol 1 % Injectable Suspension and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2022to 25 Nov 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between age group of 20-60 years
- Both male and female patients.
- American Society of Anesthesiologist (ASA) physical status I-II
- Elective ERCP procedure.
Who cannot join
- Patients allergic to any study drug.
- American Society of Anesthesiology (ASA) Physical status III-IV
- Patients with uncontrolled Diabetes Mellitus,
- Hypertension and renal insufficiency.
- Body mass index (BMI) over 36 Kilogram/m2 (Morbid obesity)
- Obstructive Sleep Apnea
- Gastroesophageal reflux disease (GERD)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography
After approval of ethical committee of Sindh Institute of Urology \& Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg intravenously was used to rescue the sedation level in both groups
Read the detailed description
After approval of ethical committee of SIUT, 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by history of patients, general physical examination, systematic examination, and laboratory investigations. Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kilogram/min started for maintenance of anaesthesia.
When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2), noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and baseline readings will be recorded. After that venous access was secured on a non-dominant hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8 ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken, after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure ends.
Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more than 10 seconds or patient developed apnea, it was considered oxygen desaturation.
Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40 beats per minute was considered bradycardia and it will be managed by inj Atropine 10 ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or 20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or vasopressors.
After the procedure, patients were awakened and shifted to recovery room. Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated accordingly.
- Conditions
- Sedation Complication
- Being tested
- Propofol 1 % Injectable Suspension, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 1 % Injectable SuspensionDrug
Also called Propofol
Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously
SevofluraneDrug
Also called Sevoflurane inhalation anaesthetic
Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol at a rate of 50 microgram/kg/min Receives: Drug: Propofol 1 % Injectable Suspension |
| Sevoflurane | Experimental | Sevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25 Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ramsay sedation score
Clinical Score Patient's Characteristics
- Awake; agitated or restless or both
- Awake; cooperative, oriented, and tranquil
- Awake but responds to commands only
- Asleep; brisk response to light glabellar tap or loud auditory stimulus
- Asleep; sluggish response to light glabellar tap or loud auditory stimulus
- Asleep; no response to glabellar tap or loud auditory stimulus
Measured: 0-2 hours
Heart rate
Heart rate via vitals monitoring device
Measured: 0-2 hours
Mean arterial blood pressure
Mean arterial blood pressure via a non-invasive blood pressure monitor
Measured: 0-2 hours
Oxygen saturation
Oxygen saturation via a pulse oximeter
Measured: 0-2 hours
Respiratory rate
Respiratory rate via a vitals monitoring device
Measured: 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start5 Jan 2022
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation
- Investigators
- Muhammad Q Abbas, FCPS, Study chair, Professor Dept of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996588
- Sponsor's protocol ID
- SIUT-ERC-2021/A-325
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT05996588
- Acronym / sponsor ID
- SIUT-ERC-2021/A-325
- Conditions
- Sedation Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 18 Aug 2023 (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.
After approval of ethical committee of Sindh Institute of Urology \& Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg intravenously was used to rescue the sedation level in both groups
Detailed description
After approval of ethical committee of SIUT, 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by history of patients, general physical examination, systematic examination, and laboratory investigations. Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kilogram/min started for maintenance of anaesthesia.
When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2), noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and baseline readings will be recorded. After that venous access was secured on a non-dominant hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8 ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken, after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure ends.
Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more than 10 seconds or patient developed apnea, it was considered oxygen desaturation.
Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40 beats per minute was considered bradycardia and it will be managed by inj Atropine 10 ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or 20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or vasopressors.
After the procedure, patients were awakened and shifted to recovery room. Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofol 1 % Injectable SuspensionPropofol at a rate of 50 microgram/kg/min |
| Sevoflurane | Experimental | Drug: SevofluraneSevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between age group of 20-60 years
- Both male and female patients.
- American Society of Anesthesiologist (ASA) physical status I-II
- Elective ERCP procedure.
Key exclusion criteria (8 listed)
- Patients allergic to any study drug.
- American Society of Anesthesiology (ASA) Physical status III-IV
- Patients with uncontrolled Diabetes Mellitus,
- Hypertension and renal insufficiency.
- Body mass index (BMI) over 36 Kilogram/m2 (Morbid obesity)
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 |
|---|---|---|
| Propofol 1 % Injectable SuspensionAlso: PropofolPropofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously | Drug | Propofol |
| SevofluraneAlso: Sevoflurane inhalation anaestheticSevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25 | Drug | Sevoflurane |
Primary outcome
Ramsay sedation score
Time frame: 0-2 hours
Clinical Score Patient's Characteristics 1. Awake; agitated or restless or both 2. Awake; cooperative, oriented, and tranquil 3. Awake but responds to commands only 4. Asleep; brisk response to light glabellar tap or loud auditory stimulus 5. Asleep; sluggish response to light glabellar tap or loud auditory stimulus 6. Asleep; no response to glabellar tap or loud auditory stimulus
Heart rate
Time frame: 0-2 hours
Heart rate via vitals monitoring device
Mean arterial blood pressure
Time frame: 0-2 hours
Mean arterial blood pressure via a non-invasive blood pressure monitor
Oxygen saturation
Time frame: 0-2 hours
Oxygen saturation via a pulse oximeter
Respiratory rate
Time frame: 0-2 hours
Respiratory rate via a vitals monitoring device
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 18 Aug 2023.
- 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.
Muhammad Q Abbas, FCPS study chair
Professor Dept of Anaesthesiology
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 Propofol 1 % Injectable Suspension and Sevoflurane in people with Sedation Complication, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
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 8 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 18 Aug 2023. 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 Pakistan. 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?
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?
Ramsay sedation score (time frame: 0-2 hours). 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 18 Aug 2023.