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Dexmedetomidine and Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03172065
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rasha Hamed, Assiut University

Brief Summary:

Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered


Condition or disease Intervention/treatment Phase
Anesthesia Complication Drug: Normal saline Drug: Dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
control group
will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline
Drug: Normal saline
intravenous flluid

Dexmedetomidine group
will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)
Drug: Dexmedetomidine
anaesthetic adjuvants and pain killer medication.




Primary Outcome Measures :
  1. occurrence shoulder tip pain [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. intraoperative haemodynamic stability, et co2, sao2. [ Time Frame: 2 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective gynaecological laparoscopic surgery
  • Age 20-45 yrs
  • Suspected surgery time 30 minutes
  • Inflation pressure <13 Cm H20

Exclusion Criteria:

  • Contraindications to regional block (infection at the needle insertion site)
  • Altered conscious level.
  • Pregnancy
  • Body mass index >35
  • Height <155 cm
  • Patients who have difficulty understanding the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172065


Locations
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Egypt
Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Rasha Hamed, Lecturer of anesthesia, Assiut University
ClinicalTrials.gov Identifier: NCT03172065    
Other Study ID Numbers: IDGL
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics, Local
Anesthetics
Dexmedetomidine
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action