Adverse Effects Monitoring

Uses

Risks & contraindications

Highlighted claims

• Serious adverse events must be reported in writing to the sponsor and site ethics committee within 24 hours. — Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial
• A Data Monitoring Committee comprising ethicists, clinicians and statisticians meets quarterly to assess serious adverse events and advise on whether the trial should continue. — Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial
• Respiratory depression is defined as a respiratory rate below 12 breaths per minute with shallow breathing. — Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial
• Pruritus is measured using the Peak Pruritus Numeric Rating Scale, ranging from 0 for no itch to 10 for worst imaginable itch. — Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial
• Antiemetic prophylaxis is guided by the Apfel risk score; patients with more than two risk factors receive three antiemetics. — Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial
• Hypotension is defined as blood pressure below 75% of the preoperative baseline and is listed as a monitored adverse effect. — Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial