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Effect of Promethazine on Postoperative Nausea and Vomiting Following Temporomandibular Joint Disc Reduction and Fixation

Effect of Promethazine on Postoperative Nausea and Vomiting Following Temporomandibular Joint Disc Reduction and Fixation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125111
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-05-21
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Postoperative Nausea and Vomiting

Interventions

Control group:One milliliter of normal saline was intravenously injected 15 minutes before the end of surgery. Postoperatively, a patient - controlled intravenous analgesia (PCIA) pump was used, with
Single - dose group:Six point two five milligrams (1 mL) of promethazine injection was intravenously injected 15 minutes before the end of surgery. Postoperatively, a patient-controlled intravenous an
Combination group:Six point two five milligrams (1 mL) of promethazine injection was intravenously injected 15 minutes before the end of surgery. Postoperatively, a patient-controlled intravenous anal

Sponsors

Affiliated Stomatology Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age: 12–65 years old; 2.American Society of Anesthesiologists (ASA) physical status classification: Class 1–2; 3.Body Mass Index (BMI): 18.5–23.9 kg/m^2; 4.Definitive diagnosis of temporomandibular joint disorder (Wilkes Stage IV) and scheduled for temporomandibular joint disc reduction and fixation surgery under general anesthesia, with the operation time less than 3 hours.

Exclusion criteria

Exclusion criteria: 1.Allergy to the investigational drug. 2.Pregnant or lactating females. 3.Patients complicated with glaucoma, benign prostatic hyperplasia, epilepsy, or myasthenia gravis. 4.Patients with hepatic and renal insufficiency. 5.Patients with prolonged QT interval. 6.Those who have used antiemetic drugs within 48 hours before surgery. 7.History of alcohol or opioid substance abuse. 8.Preoperative coma, psychiatric symptoms or intellectual disability; or combined with underlying diseases such as cardiovascular diseases and diabetes mellitus. 9.Long-term smoking history (smoking >=10 cigarettes per day for more than 1 consecutive year). 10.Severe malformation or perforation of the articular disc, or severe destruction of anatomical structure that renders temporomandibular joint disc repositioning and fixation surgery unfeasible. 11.Participation in other clinical trials concurrently during the study intervention period.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting ;

Secondary

MeasureTime frame
Postoperative Nausea Severity Score ;Vomiting/Retching Episode Frequency Score;Postoperative Nausea and Vomiting Impact Scale Score;PONV Remission Rate;Postoperative Surgical Site Pain Score;Postoperative Rescue Antiemetic Usage;Administration status of postoperative rescue analgesics;Anesthetic emergence time;Adverse event occurrence;PACU stay time;Postoperative Ramsay Sedation Score;Postoperative basic vital signs;Surgical duration;Intraoperative anesthetic dosage;Intraoperative fluid volume;Intraoperative blood loss;

Countries

China

Contacts

Public ContactQin Zhaojun

Affiliated Stomatology Hospital of Guangzhou Medical University

qin1172001@aliyun.com+86 158 7161 9516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026