Propofol Versus Dexmedetomidine on the Incidence of Postoperative Nausea and Vomiting

NCT05875077 | Unknown DMC

• 1 other identifier: MD-62-2022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative nausea and vomiting are a leading cause of recovery room delays and low patient satisfaction. Complications such as suture line tension, wound hemorrhage and dehiscence, elevated intracranial pressure, pulmonary aspiration, dehydration, and electrolyte imbalance have been linked to nausea and vomiting. Many studies were done to explore the effects of propofol and dexmedetomidine on the incidence of post operative nausea and vomiting (PONV). In this study, we will compare propofol infusion to dexmedetomidine infusion on the incidence of PONV in patients undergoing ureteroscopic procedures under spinal anesthesia in the age group from 18 to 60 years with more than one risk factor for PONV (female, history of PONV, non-smoking).

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• primary outcome

  Number of PONV episodes in patients undergoing ureteroscopic procedures under spinal anesthesia

  6 hours

Secondary Outcomes (2)

• secondry outcome

  2 hours

• tertiary outcome

  2 hours

Study Arms (2)

Propofol group

EXPERIMENTAL

will receive propofol infusion.

Drug: Propofol

Dexmedetomidine group

EXPERIMENTAL

will receive dexmedetomidine infusion.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

compare the effects of dexmedetomidine infusion to propofol infusion during spinal anesthesia, on the incidence of postoperative nausea and vomiting in patients undergoing ureteroscopic procedures under spinal anesthesia.

Dexmedetomidine group

Propofol DRUG

compare the effects of dexmedetomidine infusion to propofol infusion during spinal anesthesia, on the incidence of postoperative nausea and vomiting in patients undergoing ureteroscopic procedures under spinal anesthesia.

Propofol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 60 years
• ASA physical status I-II
• Scheduled for ureteroscopic procedure
• With more than one Risk factor for PONV (female, history of PONV, non-smoking).

You may not qualify if:

• Patients with contraindications for spinal anesthesia including infection at the injection site, bleeding diathesis, known left ventricular outflow obstruction, hypovolemia, and increased intracranial pressure.
• History of allergy or hypersensitivity to propofol or dexmedetomidine.
• Gastrointestinal diseases e.g. gastroenteritis and gastric ulcers, ear diseases e.g. infections of middle and inner ear, liver cirrhosis.
• Those who have received antiemetic drugs within 48 hours before surgery.
• Operations lasting more than two hours.
• The patient's unwillingness.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralaini Medical School

Cairo, Egypt

RECRUITING

Related Publications (1)

• Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.

  PMID: 22290456 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

BESHOY ATEF

CONTACT

01220703346; beshoyatef01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 25, 2023
• Study Start: May 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)