Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Jie Chen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nausea and Vomiting

Treatments: Drug: Anisodamine; Drug: Glycopyrrolate

Study type: Interventional

Funder types: Other

Identifiers

NCT06045364

2023-115

Details and patient eligibility

About

This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.

Full description

This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.

Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP

Exclusion Criteria:1: Use of anticholinergic drugs

2: pregnancy

3: glaucoma

4: Myasthenia gravis

5: Obstructive gastrointestinal diseases

6: Obstructive urinary tract disease (prostatic hyperplasia)

7: Heart disease (coronary heart disease, congestive heart failure)

8: hyperthyroidism

9: Previous history of abdominal or intestinal surgery

10: Chronic renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

130 participants in 2 patient groups

Glycopyrrolate

Experimental group

Description:

During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants.

Treatment:

Drug: Glycopyrrolate

Anisodamine Group

Active Comparator group

Description:

During induction of anesthesia,10mg of Anisodamine was given intramuscular injection

Treatment:

Drug: Anisodamine