Efficacy Study of Dexmedetomidine Nasal Spray Combined With Propofol for Deep Sedation in ERCP

Summary

This prospective randomized single-blind study evaluated the safety and efficacy of combining dexmedetomidine nasal spray with propofol for ERCP (Endoscopic Retrograde Cholangiopancreatography) sedation in eligible patients aged 18-70 years undergoing elective procedures. The primary objectives were to determine: 1) whether this regimen reduced intraoperative hypoxemia (decreased blood oxygen levels), decreased propofol dosage, and improved postoperative recovery quality; 2) to assess nasal administration safety and identify potential medical issues (e.g., abnormal blood pressure or bradycardia) compared to intravenous injection and control group protocols. Participants were randomly assigned to three groups: ① nasal spray group (preoperative nasal spray of dexmedetomidine + propofol), ② intravenous group (preoperative intravenous injection of dexmedetomidine + propofol), ③ and conventional group (propofol alone).

Conditions

• Sprays
• Dexmedetomidine Induced Sedation
• Nasal Administration

Interventions

DRUG

Dexmedetomidine Injection (nasal spray) + Propofol Injection + Sufentanil Injection

1. Preoperative intervention：30 minutes before entering the operating room, 50-100μg of Dexmedetomidine Injection is administered via nasal spray in the anesthesia preparation room. 2. Induction phase：Intravenous injection of Sufentanil Injection (Yichang Renfu Pharmaceutical Co., Ltd.) at a dose of 0.1μg/kg, and Propofol Injection (Jiabo Pharmaceutical, Guangdong, China) at a dose of 1.5-2.0mg/kg (injection time \>30 seconds). During induction, the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/s) score is evaluated every 30±10 seconds; if MOAA/s \>1 after 2 minutes, an additional sedative dose (1/2 of the initial dose, injection time ≥10 seconds) is supplemented until MOAA/s ≤1. 3. Maintenance phase：Continuous intravenous infusion of Propofol Injection at a rate of 4-12mg/kg/h; the dose is adjusted according to Bispectral Index (BIS) to maintain BIS between 40-60. If the patient shows body movement, eye opening, speech or other signs of insufficient se

DRUG

Normal Saline (nasal spray) + Dexmedetomidine Injection (intravenous) + Propofol Injection + Sufentanil Injection

1. Preoperative intervention：30 minutes before entering the operating room, normal saline is administered via nasal spray in the anesthesia preparation room; 10 minutes before induction, 0.5μg/kg of Dexmedetomidine Injection is given via intravenous injection. 2. Induction phase：Same as Experimental Group ① (intravenous Sufentanil 0.1μg/kg + Propofol 1.5-2.0mg/kg, with MOAA/s monitoring and supplementary dose rules). 3. Maintenance phase：Same as Experimental Group ① (continuous Propofol infusion at 4-12mg/kg/h, BIS-adjusted dose, and supplementary sedation rules for insufficient sedation).

DRUG

Regular sedation protocol

Preoperative intervention：No dexmedetomidine or normal saline nasal spray; only routine preoperative preparation. Induction phase：Same as Experimental Group ① (intravenous Sufentanil 0.1μg/kg + Propofol 1.5-2.0mg/kg, with MOAA/s monitoring and supplementary dose rules). Maintenance phase：Same as Experimental Group ① (continuous Propofol infusion at 4-12mg/kg/h, BIS-adjusted dose, and supplementary sedation rules for insufficient sedation).

Sponsors & Collaborators

• Shanghai East Hospital of Tongji University

  collaborator OTHER

• Shiyou Wei

  lead OTHER

Principal Investigators

• Shiyou Wei, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-02

Primary Completion

2025-11-10

Completion

2025-11-12

Countries

• China

Study Locations