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Sterile Water versus Normal Saline as Diluent for Rocuronium: A Randomized Controlled Trial on Injection Pain

Sterile Water versus Normal Saline as Diluent for Rocuronium: A Randomized Controlled Trial on Injection Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120644
Enrollment
Unknown
Registered
2026-03-18
Start date
2025-09-26
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient induced with rocuronium for general anesthesia

Interventions

SA Group (Saline Group):Normal saline 15ml + Rocuronium Bromide (50mg/5ml)
ST Group (Sterile Water Group):Sterile Water for Injection 15ml + Rocuronium Bromide (50mg/5ml)

Sponsors

Shanghai Xuhui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ASA physical status I or II.Age > 18 years(Both male and female).Scheduled to undergo general anesthesia requiring rocuronium for induction.

Exclusion criteria

Exclusion criteria: 1.Known allergy to rocuronium or any contraindication to its use. 2.Hepatic or renal insufficiency, or any hematologic disorder. 3.Chronic alcoholism. 4.Long-term use of sedative-hypnotics, analgesics, or psychotropic medications. 5.Communication barriers or cognitive impairment. 6.Coexisting peripheral vascular disease. 7.Severe cardiovascular disease. 8.Failure to achieve intravenous access on the dorsum of the hand. 9.Any contraindication to intravenous cannulation in the dorsum of the hand. 10.Anticipated difficult airway. 11.Perioperative administration of any agents that may interfere with routine blood tests, biochemistry, or urinalysis, including but not limited to: blood products, sodium bicarbonate, diuretics, insulin, antiplatelet drugs, hypo-/hyper-osmolar fluids, or concentrated electrolyte solutions (e.g., potassium chloride, calcium gluconate). 12.Systemic infection or current use of corticosteroids. 13.Preoperative abnormalities in routine blood tests, biochemical profiles, or serum electrolyte levels.

Design outcomes

Primary

MeasureTime frame
Incidence of rocuronium injection pain (defined as the proportion of patients reporting a pain score of 1-4).;

Secondary

MeasureTime frame
The distribution of injection pain of different severity levels (1-4);The incidence of complications at the injection site (such as pain, swelling, allergic reactions, etc.) within 24 hours after surgery;The patients' recall of pain and other discomfort symptoms (such as limb movement and difficulty in swallowing) during anesthesia induction 24 hours after the operation.;The physical and chemical properties (pH value and osmotic pressure) of the rocuronium bromide mixture were tested and the results were as follows;the red blood cell count;haematocrit;hemoglobin;numeration of leukocyte; blood platelets count;serum sodium;serum potassium;serum chlorine;bicarbonate concentration;creatinine;carbonyldiamide;albumin;urine protein;urine creatinine;hematuria;urine specific gravity;urine ht;Intraoperative fluid infusion volume;peroperative bleeding;Type of surgery;General condition of the patient;

Countries

China

Contacts

Public ContactGong Wenyi

Shanghai Xuhui Central Hospital

gong.wy@hotmail.com+86 138 1698 3539

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026