Menstrual Cycle on Injection Pain of Rocuronium

NCT02539706 | Completed DMC

• 1 other identifier: sinan
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half of participants will receive follicular phase, while the other half will receive luteal phase.

Conditions

Pain, Menstrual

Outcome Measures

Primary Outcomes (1)

• Pain measure

  Tracheal intubating dose of 0.6 mg/kg of rocuronium at room temperature was injected over 10 -15 s. The patients were observed immediately if they had pain in the arm, and the response was assessed. Withdrawal movements were also assessed and scored as follows: no movements = 0, movement limited to hand = 1, movement limited to the forearm including the elbow joint = 2, and movement of the upper arm including the shoulder joint = 3

  10 second

Study Arms (2)

Follıcular group

EXPERIMENTAL

patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.

Drug: Rocuronium 0,6mg/kg

Luteal group

ACTIVE COMPARATOR

patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.

Drug: Rocuronium 0,6mg/kg

Interventions

Rocuronium 0,6mg/kg DRUG

patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous was applied

Also known as: esmeron

Follıcular group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology Classification (ASA) I-II
• years
• Regular menstrual cycle

You may not qualify if:

• Irregular menstrual cycles
• Patients receiving hormones or drugs affecting the ovulatory cycle
• Amenorrhea
• Pregnancy
• Climacteric patients

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Training and Research Hospital

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Adnan Menderes Univercity Medicine Faculty

  Adnan Menderes University,Faculty of Medicine, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: January 6, 2014
• Primary Completion: September 6, 2015
• Study Completion: October 6, 2015
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

TU (1)