The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy
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Purpose
To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes stretch and irritation of the peritoneum, is known to play an important role in postoperative nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay. In addition, the patient with PONV is also predisposed to severe complications such as aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay, and eventually increased medical cost.
| Condition | Intervention | Phase |
|---|---|---|
|
Robotic Radical Prostatectomy |
Drug: Propofol anesthesia |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy |
- the incidence and severity of PONV(Postoperative nausea and vomiting) [ Time Frame: 48 hours after the surgery ] [ Designated as safety issue: No ]Comparison of the incidence and severity of PONV 48 hours after the surgery.
| Enrollment: | 93 |
| Study Start Date: | December 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control group
balanced anaesthesia with antiemetic prophylaxis
|
Drug: Propofol anesthesia
In the TIVA and TIVA-P group, propofol and remifentanil were used for induction and maintenance of anaesthesia. In the control group, propofol and remifentanil were used for induction and anaesthesia was maintained with desflurane and remifentanil. In the control and TIVA-P group, ramosetron 0.3mg was administered at the end of surgery. In all patients, postoperative pain was controlled with fentanyl-based intravenous patient-controlled analgesia. he depth of anaesthesia was monitored with a bispectral index score monitor and maintained at 40-60.
|
|
Active Comparator: TIVA group
TIVA without antiemetic prophylaxis
|
Drug: Propofol anesthesia
In the TIVA and TIVA-P group, propofol and remifentanil were used for induction and maintenance of anaesthesia. In the control group, propofol and remifentanil were used for induction and anaesthesia was maintained with desflurane and remifentanil. In the control and TIVA-P group, ramosetron 0.3mg was administered at the end of surgery. In all patients, postoperative pain was controlled with fentanyl-based intravenous patient-controlled analgesia. he depth of anaesthesia was monitored with a bispectral index score monitor and maintained at 40-60.
|
|
Active Comparator: TIVA-P group
TIVA with antiemetic prophylaxis
|
Drug: Propofol anesthesia
In the TIVA and TIVA-P group, propofol and remifentanil were used for induction and maintenance of anaesthesia. In the control group, propofol and remifentanil were used for induction and anaesthesia was maintained with desflurane and remifentanil. In the control and TIVA-P group, ramosetron 0.3mg was administered at the end of surgery. In all patients, postoperative pain was controlled with fentanyl-based intravenous patient-controlled analgesia. he depth of anaesthesia was monitored with a bispectral index score monitor and maintained at 40-60.
|
Detailed Description:
To maximize the surgical visual field, Robot-assisted laparoscopic radical prostatectomy (RLRP) usually requires the patient to be positioned in a steep trendelenburg position in combination with prolonged intraperitoneal carbon dioxide (CO2) insufflation and increased intrabdominal pressure. Insufflations of CO2 during laparoscopic surgery, which causes stretch and irritation of the peritoneum, is known to play an important role in postoperative nausea and vomiting (PONV). In addition, prolonged pneumoperitoneum increases the risk for PONV. PONV can cause patient discomfort and prolong post anaesthesia care unit (PACU) stay. In addition, the patient with PONV is also predisposed to severe complications such as aspiration pneumonia, increased wound dehiscence, delayed recovery, prolonged hospital stay, and eventually increased medical cost. Therefore, as RLRP itself can be an important risk factor of PONV, the anaesthesiologist should give attention to prevent PONV in this patient group, although they usually have lower risk in terms of patient-related factors. Previously published studies have recommended antiemetic prophylaxis for the patients with moderate-to-high risk of PONV. However, despite routine use of prophylactic antiemetics, laparoscopic surgery has been associated with higher incidence of PONV.Previous clinical studies suggested that total intravenous anaesthesia (TIVA) with propofol reduced PONV significantly compared to inhaled anaesthetics. Also, several studies have recommended TIVA with propofol as the anaesthetic method in patients with high risk of PONV. However none of these studies were designed and powered to detect differences in PONV in patients undergoing laparoscopic surgery, especially RLRP.
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing RLRP, ASA physical status I or II, age 50 to 70.
Exclusion Criteria:
- Emergency operation.
- patients with motion sickness or PONV history to control anticipated risk of PONV.
- Patients with antiemetic use within 24 hours before surgery.
- Patients with regular corticosteroid use.
- Patients with chemotherapy within 4 or radiotherapy within 8 weeks.
- Patients with allergy to any of the study drugs.
- Patients with liver dysfunction, confirmed renal impairment, or obesity (body mass index > 35 kg/m2).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sun-Joon Bai / Associate Professor, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University Health System |
| ClinicalTrials.gov Identifier: | NCT01402622 History of Changes |
| Other Study ID Numbers: | 4-2010-0361 |
| Study First Received: | July 25, 2011 |
| Last Updated: | July 25, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Postoperative Nausea and Vomiting Postoperative Complications Pathologic Processes Nausea Signs and Symptoms, Digestive Signs and Symptoms Vomiting Anesthetics Propofol |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 16, 2013