Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346522
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-03-29
Brief Title:
Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Efficacy of Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort CRBD Inside the Intensive Care Unit ICU a Prospective RandomizedComparative Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Catheter-related bladder discomfort CRBD is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period CRBD shows similar symptoms to overactive bladder OAB so drugs used for the management of OAB could influence symptoms of CRBD Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder
Detailed Description:
Study will be conducted in the intensive care units ICU of Ain Shams University Hospitals Cairo Egypt
After satisfactory pain control and full recovery in the postanesthesia care unit PACU the patient will be transferred to the ICU as a case of postoperative care after elective spinal diskectomy surgeries cervical dorsal or lumber with removal of the damaged portion of the herniated or degenerated disks Admission to ICU will be for medical surgical or anesthesia related causes
Standard monitoring devices via GE monitor will be connected to the patient as electrocardiogram ECG for heart rate beatsmin pulse oximetry for SPO2 as a percentage and non-invasive blood pressure NIBP mmHgTemperature of the patient in Celsius C random blood sugar mgdl and urine output mlhour will be monitored also Follow-up by standard postoperative laboratory tests will be done too
After the patient will regain feeding according to the European Society for Clinical Nutrition and Metabolism ESPEN guidelines the consented and enrolled eighty patients will be randomly assigned to one of the following two groups and oral drug will be taken with sips of water
Group G 40 patients Gabapentin GaptinR 400mg oral capsule
Group T 40 patients Trospium chloride slow release TrospikanR SR 60mg oral capsule
Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in 1261224 hours after the study drugs intake Assessment of pain severity and control will be done by using Numerical Pain Rating Scale NPRS and measuring total fentanyl requirements in the 1st 24h in micrograms µgday Side effects of the study drugs will be recorded and managed accordingly with the use of Ramsay sedation score to assess sedation level one hour after the study drugs intake
Patients will continue their monitored care in the ICU till the control of the causes of their ICU admission or their end
Demographic data causes for postoperative care in the ICU Medical surgical or anesthesia related and spine surgery site and number for each cervical dorsal lumber will be collected and recordedThe collected study data results will be revised electronically recorded in datasheet coded tabulated analyzed and processed using the proper computerized statistical package program Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between both groups to identify any significant differences between them
After satisfactory pain control and full recovery in the postanesthesia care unit PACU the patient will be transferred to the ICU as a case of postoperative care after elective spinal diskectomy surgeries cervical dorsal or lumber with removal of the damaged portion of the herniated or degenerated disks Admission to ICU will be for medical surgical or anesthesia related causes
Standard monitoring devices via GE monitor will be connected to the patient as electrocardiogram ECG for heart rate beatsmin pulse oximetry for SPO2 as a percentage and non-invasive blood pressure NIBP mmHgTemperature of the patient in Celsius C random blood sugar mgdl and urine output mlhour will be monitored also Follow-up by standard postoperative laboratory tests will be done too
After the patient will regain feeding according to the European Society for Clinical Nutrition and Metabolism ESPEN guidelines the consented and enrolled eighty patients will be randomly assigned to one of the following two groups and oral drug will be taken with sips of water
Group G 40 patients Gabapentin GaptinR 400mg oral capsule
Group T 40 patients Trospium chloride slow release TrospikanR SR 60mg oral capsule
Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in 1261224 hours after the study drugs intake Assessment of pain severity and control will be done by using Numerical Pain Rating Scale NPRS and measuring total fentanyl requirements in the 1st 24h in micrograms µgday Side effects of the study drugs will be recorded and managed accordingly with the use of Ramsay sedation score to assess sedation level one hour after the study drugs intake
Patients will continue their monitored care in the ICU till the control of the causes of their ICU admission or their end
Demographic data causes for postoperative care in the ICU Medical surgical or anesthesia related and spine surgery site and number for each cervical dorsal lumber will be collected and recordedThe collected study data results will be revised electronically recorded in datasheet coded tabulated analyzed and processed using the proper computerized statistical package program Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between both groups to identify any significant differences between them
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None