Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction

NCT07716891 | Recruiting

• 1 other identifier: KYLL-2026-0131
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, randomized, controlled trial comparing pre-injection versus standard bolus administration of rocuronium bromide for general anesthesia induction. A total of 108 adult patients (18-65 years, ASA I-III) scheduled for elective surgery requiring endotracheal intubation will be enrolled and randomized 1:1 to either the pre-injection group or control group. The pre-injection group will receive rocuronium 0.06 mg/kg as a priming dose followed by 0.54 mg/kg 3 minutes later. The control group will receive rocuronium 0.6 mg/kg as a single bolus. All patients will receive standardized anesthesia induction with midazolam and propofol. The primary outcome is neuromuscular blockade onset time (seconds). Secondary outcomes include hemodynamic parameters (SBP, DBP, MAP, HR, CO, SV, SVR), injection pain incidence, and adverse events. This study aims to investigate whether pre-injection of rocuronium can shorten neuromuscular blockade onset time while maintaining hemodynamic stability compared to standard bolus administration.

Conditions

General Anesthesia; Elective Surgery

Keywords

Rocuronium bromide; Onset time; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Neuromuscular blockade onset time

  The time interval from injection of rocuronium bromide to maximum neuromuscular block effect

  Within 5 minutes after completion of rocuronium-bromide injection

Secondary Outcomes (10)

• Systolic Blood Pressure (SBP)

  Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。

• Diastolic Blood Pressure (DBP)

  Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。

• Mean Arterial Pressure (MAP)

  Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。

• Heart Rate (HR)

  Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。

• Cardiac Output (CO)

  Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。

Study Arms (2)

Pretreated Rocuronium Group

EXPERIMENTAL

Drug: Rocuronium Bromide (Pretreatment Injection)

Conventional Administration Group

ACTIVE COMPARATOR

Drug: Rocuronium Bromide (Conventional Injection)

Interventions

Rocuronium Bromide (Pretreatment Injection) DRUG

Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction

Pretreated Rocuronium Group

Rocuronium Bromide (Conventional Injection) DRUG

Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction

Conventional Administration Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status classification Ⅰ, Ⅱ or Ⅲ
• Elective surgery requiring general anesthesia with tracheal intubation
• Able to understand the study and voluntarily sign written informed consent
• Male or female, no gender restriction

You may not qualify if:

• Severe hepatic dysfunction (ALT/AST \> 3 times the upper limit of normal) or renal dysfunction (creatinine \> 2 times the upper limit of normal)
• Central nervous system diseases or severe neuromuscular disorders
• Severe arrhythmia or cardiac dysfunction (NYHA class Ⅲ-Ⅳ, or ejection fraction EF \< 30%)
• Known hypersensitivity or allergy to rocuronium, midazolam, propofol or other study-related drugs
• Refusal to participate in this clinical trial
• Pregnant or breastfeeding women
• History of predicted difficult airway requiring awake tracheal intubation
• Contraindications to rapid sequence induction

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, China

RECRUITING

MeSH Terms

Interventions

Rocuronium; Congresses as Topic

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Organizations; Health Care Economics and Organizations

Central Study Contacts

xiaoya chen

CONTACT

8618295266516; chenxiaoya0314@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)