A single-center, randomized, double-blind, positive parallel controlled clinical study of esketamine combined with remifentanil in anesthesia gastrointestinal endoscopy procedures

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200056591

Enrollment

Unknown

Registered

2022-02-08

Start date

2022-03-01

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Experimental group:‘’Esketamine + Remifentanil‘’ anesthesia/sedation

Control group:‘’Propofol+Remifentanil‘’ anesthesia/sedation

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Simple gastroscopy was performed; 2. There are no contraindications for painless gastroscopy; 3. American Society of Anesthesiologists (ASA) Class I-II; 4. No neurological abnormalities or family history of mental illness; 5. Voluntarily participated and signed the informed consent; 6. Complete communication ability, normal hearing and smooth response; 7. Aged 18-60 years.

Exclusion criteria

Exclusion criteria: 1. Endoscopic diagnosis and treatment techniques with complex operation or large injurious stimulation are planned (e.g., endoscopic retrograde cholangiography (ERCP), endoscopic ulrasound (EUS), endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), peroral endoscopic myotomy (POEM), enteroscopy, removal of upper gastrointestinal foreign body, esophageal varicose ligation, upper gastrointestinal hemostasis, esophageal stenosis dilatation, etc.); 2. Patients with dysfunction of heart, liver, kidney and other important organs; 3. Patients who are pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Sedation success rate;Sedation induction time;After successful induction, the incidence and severity of swallowing, body movement and choking during gastroscopy;The incidence and severity of swallowing, body movement and choking during diagnosis and treatment;Sedation and awakening time;Incidence and severity of perioperative adverse events;The satisfaction rating of patients, anesthesiologists and endoscopic operators for the anesthesia process;	—

Measure

Time frame

Sedation success rate;Sedation induction time;After successful induction, the incidence and severity of swallowing, body movement and choking during gastroscopy;The incidence and severity of swallowing, body movement and choking during diagnosis and treatment;Sedation and awakening time;Incidence and severity of perioperative adverse events;The satisfaction rating of patients, anesthesiologists and endoscopic operators for the anesthesia process;

—

Countries

China

Contacts

Public ContactXu Nan

Yangzhou Jiangdu People's Hospital

173794132@qq.com+86 15052552988

Outcome results