Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996588
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2023-07-30
Brief Title:
Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP
Sponsor:
Sindh Institute of Urology and Transplantation
Organization:
Sindh Institute of Urology and Transplantation
Study Overview
Official Title:
Comparison Between Inhalational Anesthetic Sevoflurane and Intravenous Anesthetic Propofol Infusion for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Patients were divided in two groups based on agents used for the research study Both the groups were induced by injection midazolam 006 mgkg body weight and injection nalbuphine 01 mgkg body weight In group A anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration MAC approximately 025 Whereas in Group B propofol infusion at 50 ugKgmin started for maintenance of anaesthesia Ketamine 05mgkg 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 006 mgkg body weight and injection nalbuphine 01 mgkg body weight In group A anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration MAC approximately 025 Whereas in Group B propofol infusion at 50 ugKilogrammin started for maintenance of anaesthesia
When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope Injection Ketamine 05 mgkg 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 Ringers lactate or normal saline was then started at 8 mlkghour and O2 was given by nasal prongs at 4 Lmin 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 ugKilogram intravenously IV 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
When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope Injection Ketamine 05 mgkg 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 Ringers lactate or normal saline was then started at 8 mlkghour and O2 was given by nasal prongs at 4 Lmin 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 ugKilogram intravenously IV 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None