The Effect of Total Intravenous Anesthesia With Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01402622
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 3
• Duration (Months): 6
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Robotic Radical Prostatectomy	Drug: Propofol anesthesia	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. the incidence and severity of PONV(Postoperative nausea and vomiting) [48 hours after the surgery]

   Comparison of the incidence and severity of PONV 48 hours after the surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Sun-Joon Bai, MD, Ph.D, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01402622
• Other Study ID Numbers: 4-2010-0361
• First Posted: Jul 26, 2011
• Last Update Posted: Jul 26, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting; Propofol

Study Results

No Results Posted as of Jul 26, 2011