Authors
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Medeniyet University, Goztepe Training and Research Hospital -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2019
INTERVENTION: Patients were taken to pre‐operative preparation room with their parents about 30 minutes before the surgical operation. 0.4 mg/kg midazolam was given orally to the all patients in preparation room. Then, patients were monitored and taken to the operation room. Anesthesia was induced with 8% inspired sevoflurane in 50% nitrous oxide and 50% oxygen. After anesthesia induction, sevoflurane concentration is gradually reduced and an intravenous (i.v.) catheter was inserted. Patients were assigned to dexmedetomidine or tramadol group according to a computer generated program as follows: dexmedetomidine group (group D, n = 30) and tramadol group (group T, n = 30). Patients in group D received 1 µg/kg dexmedetomidine and patients in group T received 1.5 mg/kg tramadol. Both of these drugs were administered with a 10‐minute i.v. infusion about 10 minutes before the end of the surgery. Patients were monitored, and mean arterial pressure (MAP) and heart rate (HR) were recorded. In addition to these variables, the Riker Sedation‐Agitation Scale (SAS) was used for determining the level of anxiety of the patients, and pain point scale was used for determining the level of pain of the patients. Moreover, extubating time which was defined as the time from discontinuation of inhalation agent to removal of the endotracheal tube and extubation quality which was assessed by the presence of the following not breathing (> 20 second), coughing‐bucking (frequency =4) and desaturation (saturation of O2 < 95%) after the extubation period were recorded for all patients. Dexmedetomidin group and tramadol groups were compared in terms of these variables. Anaesthetist will be administering the intervention. CONDITION: Adenotonsillectomy Surgery; ; Adenotonsillectomy Surgery Anaesthesiology ‐ Pain management PRIMARY OUTCOME: Pain Point Scale ; Post‐operative pain score was assessed with Pain Point Scale: a 10‐point scale (1 point = no pain, and 10 point = unimaginable, unspeakable).; ; [The following evaluation time points were defined for the Pain Point Scale; ‐1st minute of post operative period ; ‐15th minutes of post operative period ; ‐30th minutes of post operative period] Riker sedation‐agitation scale (SAS).; Riker SAS was assesed as follows: ; 7 (Dangerous agitation) Pulling at endotracheal tube, trying to remove catheters, climbing over bed rail, striking at staff, thrashing side to side ; 6 (Very agitated) Does not calm, despite frequent verbal reminding of limits; requires physical restraints, biting endotracheal tube ; 5 (Agitated) Anxious or mildly agitated, attempting to sit up, calms down to verbal instructions ; 4 (Calm and cooperative) Calm, awakens easily, follows commands ; 3 (Sedated) Diffi cult to arouse; awakens to verbal stimuli or gentle shaking, but drifts off again; follows simple commands ; 2 (Very sedated) Arouses to physical stimuli, but does not communicate or follow commands, may move spontaneously ; 1 (Unable to rouse) Minimal or no response to noxious stimuli, does not communicate or follow commands[The following evaluation time points were defined for the Riker Sedation‐Agitation Scale:; ‐1st minute of post operative period ; ‐15th minutes of post operative period ; ‐30th minutes of post operative period; ; ] SECONDARY OUTCOME: Extubation quality ; ] Extubation time[Extubating time was defined as the time from discontinuation of inhalation agent to removal of the endotracheal tube. ; HR was monitored with the patient Monitors (Draeger). From this monitor, HR was assessed. ; [The following evaluation time points were defined for the HR: ; Its formula was as follows: [(2 x DBP) + SBP] / 3. ; [The following evaluation time points were defined for the MAP: ; [Extubation quality was assessed with the following parameters: The presence of the not breathing (greater than 20 second), coughing‐bucking (frequency is greater than or equal to 4) and desaturation (saturation of O2 is less than 95%) after the extubation period. These parameters were recorded for all patients. Extubation quality was assessed according to the presence of these parameters. If any of these were not available, it called a quality extubation. ; Extubating time was assessed with tool (a clock). The time was started with the discontinuation of inhalation agent and ended with the removal of the endotracheal tube. The time between this two point was defined as Extubating time.] Heart rate (HR). Patients were monitored and heart rate was obtained from this monitoring. Patient monitoring was started at pre‐operative period and was contined until 30 min after operation. Heart rate was defined as number of beats per minute. ; T0, before induction (basal); T1, 20 min after induction during the procedure; T2, immediately before study drugs infusion (D or T); T3, 5th min. of study drugs infusion; T4, 10th min. of study drugs infusion; T5, 1st min of post extubating; T6, 15st min. of post‐operative period; T7, 30st min. of post‐operative period.] Mean arterial pressure ; Patients were monitored and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with automatic sphygmomanometer. Patient monitoring was started at pre‐operative period and was contined until 30 min after operation. MAP was automatically calculated from SBP and DBP vales by patient monitoring. ; T0, before induction (basal); T1, 20 min after induction during the procedure; T2, immediately before study drugs infusion (D or T); T3, 5th min. of study drugs infusion; T4, 10th min. of study drugs infusion; T5, 1st min of post extubating; T6, 15st min. of post‐operative period; T7, 30st min. of post‐operative period.] INCLUSION CRITERIA: A total of 60 children patients undergoing adenotonsillectomy surgery, aged between 2‐ 9 years and with American Society of Anesthesiologist (ASA) grades I or II, were included in this randomized study.
Epistemonikos ID: d25dd61cafc82b728117ad1821e51a3fd09b7f95
First added on: Aug 24, 2024