Efficacy of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Prospective Randomized Study

General Information purpose of research：To evaluate the safety and effectiveness of right mebromide nasal spray combined with propofol in endoscopic retrograde cholangiopancreatography.

Patients with no restriction on gender, aged 18-70 years, with a BMI of 18-30 kg/m², and American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ.

Exclusion criteria: - Patients who explicitly refused to participate in the study; - Patients with difficult airway management (modified Mallampati score of Grade IV); - Patients with anemia or thrombocytopenia (Hb < 90 g/L, PLT < 80×10⁹/L); - Patients with abnormal liver or kidney function; - Patients with a history of nasal surgery/trauma or deviated nasal septum; - Patients with allergies or contraindications to dexmedetomidine, opioids, propofol, rocuronium, or their components; - Patients with a history of abnormal recovery from previous surgery or anesthesia.

Patients were divided into three groups using a random number table method: pre-intranasal spray combined with infusion group (PP group), conventional intravenous combined with infusion group (CP group), and control group (C group).

Anesthetic Method All patients fasted from liquids for 4 hours and solids for 8 hours before surgery. Upon entering the pre-anesthesia preparation room, an upper limb venous access was established, and sodium bicarbonate Ringer's solution was infused at a rate of 300 mL/h. After entering the operating room, the patient assumed a "lateral prone position" and received oxygen via a nasal cannula at a flow rate of 5 L/min until the completion of ERCP and full awakening. All ERCP procedures were performed by experienced endoscopists. Non-invasive blood pressure, heart rate, electrocardiogram, pulse oxygen saturation, and bispectral index (BIS) were monitored. An anesthetic machine, laryngeal mask, endotracheal tube, rescue equipment, and drugs were prepared. Anesthetics were infused through the forearm venous access of the patient. Anesthetic induction methods: - Experimental Group ① (PP group): Thirty minutes before entering the operating room, 50-100 μg of dexmedetomidine injection was administered via intranasal spray in the pre-anesthesia preparation room (Administration method: Hold the dexmedetomidine nasal spray upright. Keep the nozzle away from the mouth, nose, eyes, and other body parts. Place the index and middle fingers on both sides of the top of the spray pump, and the thumb at the bottom of the bottle. Press the spray pump downward with uniform force using the index and middle fingers for 7 times, and at least one complete spray should be observed within these 7 presses. Clean the nostrils before use to ensure the nasal cavity is dry and clean. The patient should be in a sitting position with the head slightly tilted forward, and the product should remain upright during use. Insert the nozzle of the nasal spray into the nostril at an angle consistent with the nasal cavity. Press the spray pump downward fully with uniform force using the index and middle fingers (1 spray). After spraying 1 dose into each nostril, tilt the head slightly backward and inhale gently. After a 30-second interval, spray another dose into each nostril, with a total of 2-4 sprays). Upon entering the operating room, induction was performed with intravenous sufentanil (Yichang Renfu Pharmaceutical Co., Ltd.) at a dose of 0.1 μg/kg and propofol (Jiabo Pharmaceutical, Guangdong, China) at a dose of 1.5-2.0 mg/kg (intravenous injection time > 30 seconds). During induction, the modified Observer's Assessment of Alertness/Sedation (MOAA/s) scale score was evaluated every 30±10 seconds. If the MOAA/s score was still > 1 after 2 minutes, additional sedatives were supplemented (supplementary dose = 1/2 of the initial dose, injection time ≥ 10 seconds). When the patient's MOAA/s score ≤ 1, the endoscopist began to insert the endoscope and continued to infuse sedatives. - Experimental Group ② (CP group): Thirty minutes before induction, normal saline was administered via intranasal spray; 10 minutes before induction, 0.5 μg/kg of dexmedetomidine was administered intravenously. Induction was performed with sufentanil (0.1 μg/kg) and propofol (1.5-2.0 mg/kg), and the remaining procedures were the same as those in the PP group. - Control Group (C group): Induction was performed with sufentanil (0.1 μg/kg) and propofol (1.5-2.0 mg/kg), and the remaining procedures were the same as those in the two experimental groups. At the end of ERCP, the MOAA/s score was evaluated every 3 minutes until the patient was fully awake (MOAA/s score = 5 in three consecutive evaluations). After surgery, the Aldrete score was calculated every 5 minutes, and the patient was transferred from the post-anesthesia care unit (PACU) to the ward when the score reached ≥ 9 in three consecutive evaluations.