Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty

NCT06966518 | Recruiting

• 1 other identifier: 36264PR1199/4/25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.

Conditions

Intraoperative; Ketamine; Magnesium Sulfate; Postoperative Analgesia; Rhinoplasty

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Rescue analgesia of morphine will be given as a 3 mg bolus if the numeric rating scale (NRS) \> 3, to be repeated after 30 min if pain persists until the NRS \< 4.

  24 hours postoperatively

Secondary Outcomes (6)

• Time to the 1st rescue analgesia.

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Mean arterial pressure

  Till the end of surgery (Up to 2 hours)

• Degree of patient satisfaction

  24 hours postoperatively

Study Arms (2)

KM Group

EXPERIMENTAL

Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr.

Drug: Ketamine and Magnesium Sulfate

Control group

PLACEBO COMPARATOR

Patients will receive saline 0.9% as a control group.

Drug: Saline 0.9%

Interventions

Ketamine and Magnesium Sulfate DRUG

Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr.

KM Group

Saline 0.9% DRUG

Patients will receive saline 0.9% as a control group.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I - II.
• Scheduled for rhinoplasty under general anesthesia.

You may not qualify if:

• Receiving analgesic or any medications since 48 hours before the surgery.
• Drug addiction.
• Cardiovascular disease.
• Respiratory disease, renal, liver, metabolic and neurological disease.
• Pregnancy or breast feeding.
• Asthma.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Ketamine; Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Central Study Contacts

Sarah A Afifi, MD

CONTACT

0501035864; Sarah606060@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 12, 2025
• Study Start: May 12, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)