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Completed

NCT Number: NCT01402622

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

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.

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Key information

Conditions

Robotic Radical Prostatectomy

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

propofol anesthesia

Drug

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.

Primary outcomes

  1. the incidence and severity of PONV(Postoperative nausea and vomiting)

    Time frame: 48 hours after the surgery

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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