To Determine the Effectiveness of Saddl… | Clinical Trial

Key information

Conditions

Haemodynamic Instability

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Muhammad Wajid Iqbal

Karachi, Sindh, 74600, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5% Hyperbaric Bupivacaine

Drug

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

Other names: Hyperbaric Bupivacaine

Primary outcomes

Haemodynamic status

Time frame: Haemodynamic 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 usage

Time frame: Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery

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.

Sponsors and collaborators

Lead sponsor

Hamdard University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Mar 18, 2022
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed