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

Gynecological Disorder Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547608
• Other study ID #: WonkwangUH7
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 4, 2020

Study information

• Verified date: September 2020
• Source: Wonkwang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 4, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gynecological Disorder

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	WonwangUH	Iksan	Jeonbuk

Sponsors (1)

Lead Sponsor	Collaborator
Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Ayoglu H, Altunkaya H, Ozer Y, Yapakçi O, Cukdar G, Ozkoçak I. Does dexmedetomidine reduce the injection pain due to propofol and rocuronium? Eur J Anaesthesiol. 2007 Jun;24(6):541-5. Epub 2007 Jan 23. — View Citation

Cheng JC, Erpelding N, Kucyi A, DeSouza DD, Davis KD. Individual Differences in Temporal Summation of Pain Reflect Pronociceptive and Antinociceptive Brain Structure and Function. J Neurosci. 2015 Jul 1;35(26):9689-700. doi: 10.1523/JNEUROSCI.5039-14.2015. — View Citation

Hwang SM, Cho SH, Lim SY, et al. The efficacy of BIS monitoring for the preventing of withdrawal movement on the intravenous injection of rocuronium. Korean J Anesthesiol 2005;49:293-7.

Lim BG, Lee IO, Kim YS, Won YJ, Kim H, Kong MH. The utility of bispectral index monitoring for prevention of rocuronium-induced withdrawal movement in children: A randomized controlled trial. Medicine (Baltimore). 2017 Jan;96(2):e5871. doi: 10.1097/MD.0000000000005871. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the grade of rocuronium induced withdrawal movement.	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	during anesthesia induction
Secondary	visual analog scale (VAS) for injection pain	check VAS for pain after propofol administration. visual analog scale with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain	during anesthesia induction
Secondary	VAS for pain	check VAS with 100 mm for pain after surgery. 0 = no pain, 100 = the worst pain	at 1 hour, 24 hours and 48 hours
Secondary	Patient controlled analgesia (PCA) Opioid consumption	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.	at 24 and 48 hours