Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation

Klinikum Hildesheim GmbH

Status and phase: Completed; Phase 4

Conditions: Muscle Trauma; Analgetic Consumption; Total Hip Replacement; Muscle Relaxation

Treatments: Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT01228162

Nr. 5615 Hanover Med. School

Details and patient eligibility

About

The researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patient agreement
2. indication for total hip replacement
3. age 55 - 80 years
4. weight 65 - 95 kg
5. first intervention
6. ASA classification I - III
7. general and spinal anaesthesia possible in this patient

Exclusion criteria

a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

general anaesthesia

Experimental group

Description:

patients receiving general anaesthesia and rocuronium bromide for muscle relaxation

Treatment:

Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation

spinal anaesthesia

Active Comparator group

Description:

patients receiving spinal anaesthesia without muscle relaxation

Treatment:

Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation