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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05285800
Enrollment
60
Registered
2022-03-18
Start date
2021-09-06
Completion date
2022-03-06
Last updated
2022-03-31

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

Conditions

Haemodynamic Instability

Brief summary

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

Detailed description

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

Interventions

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

Sponsors

Hamdard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Haemodynamic statusHaemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.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.
Vasopressor usageBlood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgeryThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026