Balanced Propofol Sedation can be safely and effectively used for diagnostic endoscopy

Researchers from South Korea reported that compared with traditional sedation, balanced propofol sedation (BPS) using propofol in combination with midazolam and piperidine provided higher satisfaction of medical staff, better patient cooperation and similar adverse events among patients receiving endoscopic therapy. This is the first prospective study to directly compare BPS with conventional sedatives. The researchers noted that this study provides further evidence to support the use of endoscope guided BPS therapeutic endoscopes.

The study was published in the February issue of GIE: Gastrointestinal Endoscopy, a peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy (ASGE).

Propofol sedative gastroenteroscopy (GI) has become popular in the world. In recent years, propofol has been safely and effectively used in advanced interventional endoscopic surgery, such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasonography (EUS), even for high-risk patients. However, compared with diagnostic endoscopes, interventional endoscopes usually require longer operation time, larger propofol doses, and possibly more frequent dose related side effects. Propofol has some shortcomings in terms of pharmacokinetics, so the use of propofol for gastrointestinal endoscopy by non anesthesiologists is still a highly controversial issue.

Balanced Propofol Sedation (BPS) is a combination of low dose propofol increment and single induction dose benzodiazepines and opioids under the guidance of non anesthesiologists. Because BPS usually aims at moderate sedation, appropriate amnesia and analgesia can be used together with benzodiazepines and opioids.

"Several prospective studies have shown that BPS can be safely and effectively used for diagnostic endoscopy under the guidance of gastroenterologists. However, in therapeutic endoscopy, there are few controlled studies that directly compare BPS with traditional sedatives," said Chang Kyun Lee, the lead author of the study and a medical doctor from the Medical School of Kyung Hee University Hospital in Seoul, South Korea. "The purpose of this study is to compare the safety and effectiveness of BPS, propofol combined with midazolam and piperidine with traditional sedation, midazolam and piperidine in patients undergoing gastrointestinal endoscopy. We found that BPS provides higher satisfaction of medical staff, better patient cooperation, and it is similar to traditional sedation adverse events."

Method

The purpose of this study was to compare the safety and efficacy of BPS (propofol combined with midazolam and piperidine) and conventional sedation (midazolam and piperidine) in patients receiving endoscopic therapy. The primary outcome measures were the incidence of sedation related cardiopulmonary complications and surgical interruption, the duration of surgery, and the evaluation of health care providers (endoscopy doctors and sedation nurses) and patients.

This is a single center, prospective, randomized, single blind study of 222 consecutive patients treated with esophagogastroduodenoscopy (also known as EGD or upper gastrointestinal endoscopy) or ERCP between July 2009 and March 2010. All endoscopic operations were performed by five experienced endoscopic doctors, who were teachers in the hospital. The patients were randomly assigned to one of the two sedative regimens (conventional group [midazolam and piperidine] vs BPS group [propofol combined with midazolam and piperidine]) through the computer-generated random sequence. Randomized grouping and drugs for sedation and analgesia were concealed from all patients, endoscopic doctors, endoscopic nurses and nurses in the rehabilitation room. However, sedation nurses and research nurses were not blind.

All sedatives and analgesics used in this study were used by trained registered nurses, who had advanced cardiac life support certification and were supervised by an endoscopic doctor. Nurses using sedatives and analgesics are committed to drug management and patient monitoring. The target level of sedation is based on moderate sedation at the American Society of Anesthesiology (ASA) level. All patients were monitored for heart rate, blood pressure and oxygen saturation until they were completely recovered. At the end of the operation, both the endoscopy doctor and the sedation nurse completed a questionnaire. If the inpatients are confirmed to have fully recovered, they also completed a questionnaire on overall satisfaction with sedation and surgery.

Result 

There was no significant difference in the average time of induction, endoscopic surgery and recovery between the two groups. There was no significant difference between the BPS group and the conventional group in the incidence of cardiopulmonary complications (8.8% vs. 5.8%) and the incidence of temporary interruption of surgery (2.9% vs. 0). No patient needed auxiliary ventilation or early termination of surgery. Compared with conventional sedation, BPS provides significantly higher satisfaction of medical staff (according to reports of endoscopy doctors and sedation nurses), and patients in the BPS group cooperate significantly better. The satisfaction of sedative nurses with BPS was higher than that of routine sedative nurses, and the difficulty of induction and satisfaction with the process were higher than those of routine sedative nurses. The patient assessment results were similar in both study groups. However, compared with the conventional group, patients in the BPS sedation group reported significantly less endoscopic insertion and withdrawal memory. 

The researchers concluded that this study provides further evidence for the use of endoscopic guided BPS in therapeutic endoscopy.

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