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

NCT07204106 | Completed DMC

• 1 other identifier: 20250527IIT0060
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Dexmedetomidine Induced Sedation; Nasal Administration; Sprays

Keywords

Dexmedetomidine; Nasal Spray; Sedation; ERCP

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative hypoxemia

  (SpO₂ \< 90% for more than 10 seconds)

  From the start of the surgery to 1 hour after the surgery

Secondary Outcomes (4)

• Blood pressure fluctuations

  on entry to the operating room (T0), after induction (T1), when the endoscope entered the esophagus (T2), during duodenal papillary intubation (T3), when the endoscope was removed (T4), and at awakening (T5).

• Heart rate fluctuations

  on entry to the operating room (T0), after induction (T1), when the endoscope entered the esophagus (T2), during duodenal papillary intubation (T3), when the endoscope was removed (T4), and at awakening (T5).

• SpO₂ fluctuations

  on entry to the operating room (T0), after induction (T1), when the endoscope entered the esophagus (T2), during duodenal papillary intubation (T3), when the endoscope was removed (T4), and at awakening (T5).

• Incidence of intraoperative adverse events

  From the start of the surgery to 1 hour after the surgery

Other Outcomes (5)

• dosages of propofol

  From the start of the surgery to the end of the surgery

• Extubation time

  From entering the PACU to leaving the PACU

• Steward score

  From entering the PACU to leaving the PACU

Study Arms (3)

Experimental Group ①

EXPERIMENTAL

Dexmedetomidine Nasal Spray Group

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

Experimental Group ②

ACTIVE COMPARATOR

Dexmedetomidine Intravenous Group

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

Control Group

SHAM COMPARATOR

Propofol Alone Group

Drug: Regular sedation protocol

Interventions

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

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

Also known as: Dexmedetomidine Injection (nasal spray)

Experimental Group ①

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

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).

Also known as: Dexmedetomidine Injection (intravenous)

Experimental Group ②

Regular sedation protocol DRUG

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).

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyou Wei: lead
• Shanghai East Hospital of Tongji University: collaborator

Study Sites (1)

Shanghai East Hospital,Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Nasal Sprays; Propofol; Sufentanil; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Shiyou Wei, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: While the anesthesiologists who collected data during ERCP were not blinded, they were excluded from analyzing the follow-up results. The anesthesia was administered by the same experienced anesthesiologist, with post-anesthesia evaluation and follow-up care handled by a different physician. Neither the patients nor the data collectors were aware of the sedation protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Model Details: Three-group, parallel-controlled trial, designed to investigate the efficacy and safety of dexmedetomidine nasal spray in the application of ERCP (Endoscopic Retrograde Cholangiopancreatography), serving as a substitute for intravenous pump infusion of dexmedetomidine.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: October 2, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 12, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)