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Completed

NCT Number: NCT04547608

Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain

Temporal summation of pain, which is defined as the perception of increasingly greater pain evoked by repetitive painful stimuli, is highly variable between individuals. This study aimed to determine the impact of the timing of rocuronium after induction with propofol on temporal summation of pain in gynecologic laparoscopic surgery.

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Key information

Conditions

Gynecological Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

19 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

WonwangUH

Iksan, Jeollabuk-do, 570-711, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective gynecologic laparoscopic surgery
  • American Society of Anesthesiologists' physical status class) I-II

Exclusion criteria

  • Menopause (to exclude the hormonal effect on pain)
  • Patients who had muscular, cardiovascular, hepatic or kidney disorders and patients with a history of medication who would affect muscle relaxants were excluded from this study.
  • Patients with difficult venous access on forearm, a known allergy to propofol or rocuronium, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, were excluded from the study.

Treatment and study plan

The difference of the timing of rocuronium administration after propofol injection

Other

The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.

Primary outcomes

  1. the grade of rocuronium induced withdrawal movement.

    Time frame: during anesthesia induction

    withdrawal movements were graded by the investigator according to the following scale:

    • - no pain (no response);
    • - mild pain (movement at wrist only);
    • - moderate pain (movement involving the arm only with elbow or shoulder);
    • - severe pain (generalized response or movement in more than one extremity

Secondary outcomes

  1. visual analog scale (VAS) for injection pain

    Time frame: during anesthesia induction

    check VAS for pain after propofol administration. visual analog scale with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain

  2. VAS for pain

    Time frame: at 1 hour, 24 hours and 48 hours

    check VAS with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain

  3. Patient controlled analgesia (PCA) Opioid consumption

    Time frame: at 24 and 48 hours

    check the volume of PCA Opioid consumption (ml) (PCA) pump containing fentanyl (800 ug), ketorolac (150 mg), and ramosetron (0.6 mg) in a total volume of 150 mL of saline was set to deliver a basal infusion of 2 mL/h and bolus doses of 0.5 mL, with a 15-min lockout period for postoperative analgesia.

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

The Impact of the Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain in Gynecologic Laparoscopic Surgery-prospective and Controlled Study.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Sep 16, 2020

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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