Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-12-06
Brief Title:
The Effect of Preemptive Pregabalin on Postoperative Pain and Respiratory Dynamics in Robotic Prostatectomy Operation
Sponsor:
Umraniye Education and Research Hospital
Organization:
Umraniye Education and Research Hospital
Study Overview
Official Title:
The Effect of Preemptive Administration of Pregabalin on Postoperative Pain and Respiratory Dynamics in Patients Undergoing Surgery for Robotic Radical Prostatectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
The study aimed to investigate the impact of preemptive pregabalin on the postoperative pain severity and the requirement of analgesic drugs in patients undergoing robotic radical prostatectomy surgery as primary outcome
Additionally it examined the effect of pregabalin on early postoperative respiratory dynamics as secondary outcome
Additionally it examined the effect of pregabalin on early postoperative respiratory dynamics as secondary outcome
Detailed Description:
Our study will be conducted on a total of 90 patients after ethics committee approval and patient consent In the prospective observational study patients will be divided into two groups those who received preoperative pregabalin and those who did not
Group 1 those who did not take pregabalin n45 Group 2 those who took pregabalin n45 Procedure to be applied interventions Those who have received pregabalin treatment drink 150 mg of pregabalin with a small amount of water 2 hours before the surgical procedure All patients receive standard general anesthesia in the operating room after standard hemodynamic monitoring invasive arterial pressure and Bispectral Index BIS monitoring
Afterwards all patients receive standard anesthesia maintenance and are monitored in mechanical ventilation volume-controlled mode PEEP at 7-8 cmH20 and ETCO2 level at 30-35mmHg during the pneumoperitoneum period During the pneumoperitoneum period intra-abdominal pressure is kept within the range of 12-14 mmHg
During robotic surgery the standard 45-degree upright Trendelenburg position and perioperative restrictive fluid management are performed For postoperative analgesia 006 mgkg morphine 1 gram g paracetomol and 8 mg onasetron are administered iv to all patients 30 minutes before the end of the operation At the end of surgery and after extubation patients are taken from the recovery unit to the service in accordance with Aldrete criteria In the service all patients are given paracetamol 1g every 8 hours and tenoxicam 20 mg every 24 hours for pain treatment Tramadol 1 mgkg iv is administered as rescue analgesic to patients with a VAS score 4
Recording Data Patients age gender BMI and comorbidities are recorded Perioperative heart rate HR mean arterial pressure MAP peripheral oxygen saturation SpO2 BIS value ETCO2 PaCO2 arterial blood gas PaO2Fi02 and peak airway pressure Ppeak plateau pressure Pplato is recorded at the times specified below
T0 10th minute after anesthesia induction supine position 00 T1 10 minutes after the start of pneumoperitoneum supine position 00 T2 30 minutes after the upright Trendelenburg position 450 T3 At the end of pneumoperitoneum supine position 00 T4 30 minutes after extubation recovery unit The FEV1 FVC FEV1FVC values of all patients in the routine respiratory function test performed preoperatively and on the second postoperative day are recorded
Operation time Trendelenburg time perioperative urine amount and general fluid balance are recorded
Postoperative pain levels of all patients were 30 minutes and 6 12 24 36 days after extubation It is evaluated and recorded with VAS Visual Analog Scale between 0-10 at the 48th and 48th hours
Analgesic medications administered postoperatively time of first rescue analgesic tramadol administration total tramadol consumption amount presence of nausea-vomiting dizziness visual impairment presence of upper airway problems pulmonary and surgical complications are recorded
Group 1 those who did not take pregabalin n45 Group 2 those who took pregabalin n45 Procedure to be applied interventions Those who have received pregabalin treatment drink 150 mg of pregabalin with a small amount of water 2 hours before the surgical procedure All patients receive standard general anesthesia in the operating room after standard hemodynamic monitoring invasive arterial pressure and Bispectral Index BIS monitoring
Afterwards all patients receive standard anesthesia maintenance and are monitored in mechanical ventilation volume-controlled mode PEEP at 7-8 cmH20 and ETCO2 level at 30-35mmHg during the pneumoperitoneum period During the pneumoperitoneum period intra-abdominal pressure is kept within the range of 12-14 mmHg
During robotic surgery the standard 45-degree upright Trendelenburg position and perioperative restrictive fluid management are performed For postoperative analgesia 006 mgkg morphine 1 gram g paracetomol and 8 mg onasetron are administered iv to all patients 30 minutes before the end of the operation At the end of surgery and after extubation patients are taken from the recovery unit to the service in accordance with Aldrete criteria In the service all patients are given paracetamol 1g every 8 hours and tenoxicam 20 mg every 24 hours for pain treatment Tramadol 1 mgkg iv is administered as rescue analgesic to patients with a VAS score 4
Recording Data Patients age gender BMI and comorbidities are recorded Perioperative heart rate HR mean arterial pressure MAP peripheral oxygen saturation SpO2 BIS value ETCO2 PaCO2 arterial blood gas PaO2Fi02 and peak airway pressure Ppeak plateau pressure Pplato is recorded at the times specified below
T0 10th minute after anesthesia induction supine position 00 T1 10 minutes after the start of pneumoperitoneum supine position 00 T2 30 minutes after the upright Trendelenburg position 450 T3 At the end of pneumoperitoneum supine position 00 T4 30 minutes after extubation recovery unit The FEV1 FVC FEV1FVC values of all patients in the routine respiratory function test performed preoperatively and on the second postoperative day are recorded
Operation time Trendelenburg time perioperative urine amount and general fluid balance are recorded
Postoperative pain levels of all patients were 30 minutes and 6 12 24 36 days after extubation It is evaluated and recorded with VAS Visual Analog Scale between 0-10 at the 48th and 48th hours
Analgesic medications administered postoperatively time of first rescue analgesic tramadol administration total tramadol consumption amount presence of nausea-vomiting dizziness visual impairment presence of upper airway problems pulmonary and surgical complications are recorded
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