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NCT Number: NCT07815431

MC1R Mutations Associated With Red Hair and Perioperative Anesthesia Complications

The study aims to investigate whether patients with Melanocortin-1 receptor (MC1R) mutations, associated with red hair, or having a red hair phenotype, have a higher incidence of anesthesia-related perioperative complications. Genomic data from patients that have undergone a surgical or medical procedure, requiring an anesthetic management are extracted from two cohorts - a Swedish (Merged Anaesthesia and Intensive Care Cohort in Sweden (MAICS)), and a British (UK Biobank UKBB)), and linked to relevant healthcare registries. The outcome variables studied are statistically adjusted for age, gender, timing of procedure during the study period, and socioeconomic factors.

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Key information

Conditions

Anaesthesia Complication Melanocortin 1 Receptor Perioperative Adverse Events Red Hair

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University, Department of Surgical Sciences

Uppsala, 75185, Sweden

Location contact

Miklós Lipcsey, MD, PhD

CONTACT

[email protected]

0046 18 6110000

Miklós Lipcsey, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Background Perioperative complications may be associated with both suffering for the affected individuals, and a high cost for society. Available means for identifying individuals at risk should be considered.

Objective To investigate whether patients with MC1R variants (Asp84Glu, Arg142His Arg151Cys, Tyr152Ochre, Ile155Thr, Arg160Trp, Arg213Trp, Asp294His, or Arg306His) associated with red hair, or having a red hair phenotype have an increased incidence of anesthesia related perioperative complications.

Method This is a retrospective registry-based study including patients from one Swedish cohort (MAICS), and one British cohort (UKBB). MAICS is aggregation of four different cohorts; PronMed, Epihealth, Simpler, and the Swedish Twin Registry (STR). The Patients are selected from the Swedish National Patient Registry (NPR), and the Hospital Episode Statistics (HES)/NHS England using surgical and medical procedure codes known for requiring an anesthetic management in the form of general anesthesia, spinal/epidural anesthesia or regional anesthesia.

Eligible patients are associated with genotype data, and stratified into either homozygote/compound heterozygote, heterozygote, or wildtype to be able to assess whether a dose-response relationship exists between the different levels of exposures. From UKBB, a separate analysis of the association between red hair phenotype and perioperative complications is performed.

Outcome ascertainment, and the defining of cases and non-cases, is perfomed using healthcare linkage to Swedish Perioperative Registry (SPOR), Swedish Intensive Care Register (SIR), National cause of death registry (DORS), Statistics Sweden, and UKBB.

The results will be analyzed using a statistical mixed effects model, adjusted for age, sex, timing of surgery during the study period, and socioeconomic factors. The results of the genotype analysis from the two cohorts will be meta-analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A qualifying surgical procedure requiring specified anesthetic management.
  • A qualifying medical procedure requiring specified anesthetic management.
  • Caucasian origin.

Exclusion criteria

  • None specified.

Treatment and study plan

Primary outcomes

  1. Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.

    Time frame: Days 30 after a qualifying procedure.

    A composite of adverse events consisting of Death, Unplanned ICU-admission, Myocardial arrest (ICD10: I46), Myocardial infarction (ICD10: I21-22), Pneumonia (ICD10: J13-16, J18, J85, J86, A481), and Anaphylaxis (ICD10: T782, T805, T886) Up until 30 days after the procedure.

Secondary outcomes

  1. Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.

    Time frame: Days 30 after a qualifying procedure.

    The variables in the composite outcome analyzed one by one.

  2. Adverse events registered at the post anesthesia care unit (PACU)

    Time frame: Hours 24 after a qualifying procedure.

    Tachy-/bradycardia, arrythmia, angina, heart failure, hypo-/hypertension, and unexpected bleeding registered in the Swedish Perioperative Register (SPOR) from patients originating from the Swedish cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

Miklós Lipcsey, MD, PhD

CONTACT

[email protected]

0046 18 611 0000

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • County Council of Gavleborg
  • Dalarna County Council, Sweden

Registry information

Official study title

The Presence of Red Hair Associated MC1R Mutations and the Incidence of Perioperative Anesthesia Complications: A Cohort Study

Acronym: MARPAC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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