An Early Phase 1 interventional study of Dexmedetomidine injection and Normal Saline in Hypertension and Laparoscopic Cholecystectomy, sponsored by Dr. Ruth K.M. Pfau Civil Hospital, Karachi. Status unknown at 1 site in Pakistan. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Dr. Ruth K.M. Pfau Civil Hospital, Karachi · Early Phase 1, Interventional, and Prevention
Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy.
Laparoscopic surgeries form an essence of today's surgical practice because of its magnification, less cosmetic scar, less postoperative pain, and decreased hospital stay along with less morbidity and mortality.
According to the American Heart Association (AHA), approximately 86 million adults (34%) in the United States are affected by hypertension, which is defined as a systolic blood pressure (SBP) of 140 mm Hg or more or a diastolic blood pressure (DBP) of 90 mm Hg or more, taking anti-hypertensive medication of those with high blood pressure (BP), 78% were aware they were hypertensive, 68% were being treated with anti-hypertensive agents, and only 64% of treated individuals had controlled hypertension.
Anaesthetic management in these patients has become complicated due to cardiopulmonary changes occurring during creation of pneumoperitoneum with CO2 and patient position required for different laparoscopy surgeries. Effects of pneumoperitoneum for laparoscopic surgeries on heart rate and blood pressure was recognized more than 50years ago and the magnitude of the changes was observed to depend on the depth of anesthesia. The cardiovascular, neuroendocrine, and renal changes induced by the CO2 pneumoperitoneum produce a complex pathophysiological state remarkably similar to that in patients with chronic heart failure, though the initiating event is clearly very different. In normotensive subjects these hemodynamic changes are short lived5and probably of little significance. However, these haemodynamic alterations are hazardous to the patients with hypertension, myocardial insufficiency or cerebrovascular disease.
Various pharmacologic and nonpharmacological methods have been tried to limit the pressor response following the creation of pneumoperitoneum. The success rate is variable with different methods because each method has its own merits and demerits. In several clinical trials drugs like opioids, β-blockers, lidocaine, nitrate calcium channel blockers or magnesium have already been used orally or parenterally to obtund this sympathoadrenal response. Recently, there is considerable interest in the use of α2-adrenergic agonists to provide hemodynamic stability during pneumoperitoneum.
Dexmedetomidine famous for its awake sedation is eight times more selective than clonidine for the α2-adrenergic receptors. The ratio of α2:α1 activity of dexmedetomidine is 1620:1. It activates pro-survival kinases and attenuates ischemia and hypoxic injury, including cardio protection. Concurrent infusion during surgery reduces anesthetic consumption by 20-50% , and produces a decrease in heart rate and blood pressure that may be advantageous for hypertensives. Hypertension associated to pneumoperitoneum in normotensive patients has been controlled with the loading dose of dexmedetomidine. So our rational is to see the hemodynamic stability of dexmedatomindine in hypertensive patients undergoing pneumoperitoneum.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's planned enrollment of 44 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Dr. Ruth K.M. Pfau Civil Hospital, Karachi is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine
Drug: Dexmedetomidine injection
Four 50 ml syringes of .9 % Normal SALINE
Drug: Normal Saline
Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.
Also known as: dexmedetomidine
0.9% as placebo
Change in Systolic blood pressure during pneumoperitoneum
Systolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Time frame: From baseline to the end of pneumoperitonium, an average of 2 hours
change in Diastolic blood pressure during pneumoperitoneum
Diastolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Time frame: from baseline to the end of pneumoperitoneum, an average of 2 hours
change in Mean Arterial blood pressure during pneumoperitoneum
Mean Arterial blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Time frame: from baseline to the end of pneumoperitoneum, an average of 2 hours
change in Heart Rate during pneumoperitoneum
Heart rate will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively
Time frame: from baseline to the end of pneumoperitoneum, an average of 2 hours
Systolic blood pressure intubation
SBP will be noted at the induction.
Time frame: Induction
Diastolic Blood pressure intubation
DBP will be noted at the induction
Time frame: Induction
Mean Arterial blood pressure intubation
MAP will be noted at the induction.
Time frame: Induction
heart rate intubation
HR will be noted at the induction.
Time frame: Induction
Post operative sedation
Modified Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response From completion of surgery to 30 minutes post operatively
Time frame: every 5 minutes, up to 30minutes
Post operative analgesia
Visual analogue scale From completion of surgery to 30 minutes post operatively (0 no pain, 10 wost pain)
Time frame: every 5 minutes, up to 30minutes
Complication
bradycardia, tachycardia, hypertension and hypotension
Time frame: every 5 minutes from induction, up to 30 minutes post procedure
Plan to share: No
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Dr. Ruth K.M. Pfau Civil Hospital, Karachi