To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

Haemodynamic Instability Clinical Trial

Official title:

To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285800
• Other study ID #: W0333
• Status: Completed
• Phase: Phase 3
• Start date: September 6, 2021
• Est. completion date: March 6, 2022

Study information

• Verified date: March 2022
• Source: Hamdard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

Description:

This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 6, 2022
• Est. primary completion date: March 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient with absolute contraindication of general anaesthsia
• Patients who gave consent and willing to be included in study
• Patient's having age range between 45 years to 65years
• Well controlled diabetes and hypertension
• ASA grade I & II

Exclusion Criteria:

• Patients with absolute contraindications of regional anesthesia,
• Deformity of vertebral column,
• Thyroid disorder,
• Psychiatric illness,
• Neurological diseases,
• Alcohol addiction,
• Smoking,
• Ischemic heart diseases and
• Not willing to participate

Related Conditions & MeSH terms

• Haemodynamic Instability

Intervention

Drug:
• 0.5% Hyperbaric Bupivacaine
In both groups 0.5% Hyperbaric Bupivacaine is given intrathecally and then saddle group is advised to stay in sitting position for next 5minutes so that drug can block only lower segments of nerves, Lumber 5th to Sacral dermatomes level. The spinal group is advised to take supine position immediately so that drug distribution be uniform uptill T10 level of spinal dermatome. Then outcomes regarding haemodynamic status and vasopressor usage are recorded

Locations

Country	Name	City	State
Pakistan	Dr. Muhammad Wajid Iqbal	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Hamdard University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemodynamic status	Haemodynamic status includes pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation.; Pulse rate ranges between 60-100 beats/ minute. Pulse above 100 is called tachycardia and below 60 is called bradycardia Systolic blood pressure more than 140mmhg is called systolic hypertension and lower than 90mmhg is known as systolic hypotension.; Diastolic blood pressure more than 90mmhg is called diastolic hypertension and lower than 60mmhg is called diastolic hypotension.; Mean arterial pressure ranges between 70-110. More than 110 labeled as hypertension and below 70 means hypotension.; Spo2 level below 94% is labeled as hypoxia.	Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.
Primary	Vasopressor usage	The main side effect of intrathecal 0.5 % hyperbaric Bupivacaine is hypotension. That is countered by using vasopressor drug e.g inj. Ephedrine. Critically low blood pressure e.g systolic bp below 90mmhg, diastole c blood pressure below 60mmh and MAP below 60 is an indication for vasopressor introduction.	Blood pressure is taken from 0minute (as the patient takes supine position) at every 5minutes interval till the end of surgery