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To check a safety protocol to decrease Epidural Anaesthesia related complications in patients going for knee replacement surgeries: A Randomized Trial

To evaluate a safety protocol to reduce Epidural Anaesthesia related complications in patients posted for knee replacement surgeries: A Randomized Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095254
Enrollment
160
Registered
2025-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: To evaluate a safety protocol of preloading of 10 ml /kg body weight of crystalloids, prophylactic use of intravenous glycopyrrolate and also pre- instillation of normal saline (5 ml) i

Sponsors

Adesh Institute Of Medical Sciences And Research Bathinda Punjab India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-65 years All genders ASA Grade I or II Body weight 50-90 kg Patients undergoing elective knee replacement surgeries

Exclusion criteria

Exclusion criteria: Spinal deformities or anatomical abnormalities Contraindications to spinal/epidural anaesthesia Abnormal hepatic, renal, or hematological parameters Patient refusal for regional anaesthesia Known allergy to study medications

Design outcomes

Primary

MeasureTime frame
To evaluate a safety protocol of preloading of 10 ml /kg body weight of crystalloids, prophylactic use of intravenous glycopyrrolate and also pre- instillation of normal saline (5 ml) into the epidural space to prevent epidural placement related complications.Timepoint: According to Likerts Scale, easy catheter insertion is defined as if consultant who secures epidural catheter says that he/she agree (4) or strongly agree (5) that it is an easy and smooth insertion of epidural catheter. Difficult insertion will be defined as if consultant who secures epidural catheter says that he/she strongly disagree (1) or disagree (2) or undecided (3) about easiness of insertion of epidural catheter.—

Secondary

MeasureTime frame
To find out the incidence of vasovagal attacks during epidural insertion.Timepoint: ;To find out the associated complications related to epidural and the incidence of intravascular placement of epidural catheter.Timepoint: ;To find out the uniformity of epidural drug spread/two segment regression & requirement of rescue analgesia.Timepoint: ;To check the hemodynamic response.Timepoint: T0- At the start of procedure T5- 5 mins T10- 10 mins T15- 15 mins TN—

Countries

India

Contacts

Public ContactDr Sham Sunder Goyal

Adesh Institute Of Medical Sciences And Research, Bathinda(AIMSR), Punjab

drshamgoyal@yahoo.com8146832590

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026